<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262649</url>
  </required_header>
  <id_info>
    <org_study_id>REB#=HS14734 (H2002:040)</org_study_id>
    <nct_id>NCT03262649</nct_id>
  </id_info>
  <brief_title>Manitoba Inflammatory Bowel Disease Cohort Study</brief_title>
  <official_title>Manitoba Inflammatory Bowel Disease Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a&#xD;
      population-based research registry.&#xD;
&#xD;
      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline&#xD;
      survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys&#xD;
      and annually with interviews. Diagnosis and disease type were verified by chart review.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study, initiated in 2002, is study of&#xD;
      adults with IBD who have been tracked prospectively through annual clinical interviews and&#xD;
      semiannual surveys. The participants were drawn from a validated population-based research&#xD;
      registry, which identified and recruited individuals using an administrative definition of&#xD;
      IBD from the comprehensive health data base of Manitoba Health, the single insurer that&#xD;
      provides health care to all residents in the province.&#xD;
&#xD;
      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline&#xD;
      survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys&#xD;
      and annually with interviews. Diagnosis and disease type were verified by chart review. It&#xD;
      has been demonstrated that the Cohort is representative of the provincial IBD population as a&#xD;
      whole, with comparable age distribution, sex distribution, disease duration, and rural/urban&#xD;
      residence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2002</start_date>
  <completion_date type="Actual">October 1, 2016</completion_date>
  <primary_completion_date type="Actual">March 1, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Genetic Associations</measure>
    <time_frame>2010 to 2016</time_frame>
    <description>Single Nucleotide Variations (SNPs) in gene encoding for membrane transporter proteins were investigated for associations with both IBDs. Target genes included SLC23A1, SLC22A4, SLC22A5, SLC22A23, SLC2A14, SLC2A2 but analyses are not limited to these.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological Functioning 1</measure>
    <time_frame>2010-2014</time_frame>
    <description>The validated 7-item Mastery scale assesses the degree to which persons feel they have some control or mastery over their life to handle day-to-day challenges.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Efficacy</measure>
    <time_frame>2010-2014</time_frame>
    <description>The IBD- Self Efficacy (SE) is a 29-item scale developed by Keefer et al. (1) based on patient interview, validated self-efficacy measures for other diseases. The instrument assesses the level of confidence in managing various disease-related &quot;tasks,&quot; with item scores ranging from 1 (not at all) to 10 (totally), and higher scores reflecting greater disease self-management efficacy. Items were grouped conceptually into 4 subscales, reflecting domains identified by patients with IBD as important [1] managing stress and emotions (sample items: keep from feeling sad; do something to reduce stress); [2] managing medical care (sample items: take medication at instructed times; work out differences with doctors); [3] managing symptoms and disease (sample items: keep diarrhea/urgency from interfering; decrease fatigue); [4] maintaining remission (sample items: engage in self-care; maintain sense of well-being).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>2010-2014</time_frame>
    <description>The Sheehan Disability Scale is a commonly used and validated instrument that measures disease interference in 3 primary domains of life: work, social, and home, based on a visual analog scale from 0 (no interference) to 10 (very severe interference). (1,2)&#xD;
Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11(suppl 3):89-95.&#xD;
Leon AC, Olfson M, Portera L, et al. Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiatry Med. 1997;27:93-105.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health and Quality of Life 1</measure>
    <time_frame>2010-2014</time_frame>
    <description>Perceived health was assessed using the General Health item from the Medical Outcome Survey Short Form 36, (1) which asks participants to characterize their health in the past year, using 5 response categories from &quot;Excellent&quot; to &quot;Poor.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity 1</measure>
    <time_frame>2010-2014</time_frame>
    <description>Current disease activity was assessed using standardized clinical indices, the Harvey-Bradshaw index for CD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity 2</measure>
    <time_frame>2010-2014</time_frame>
    <description>Current disease activity was assessed using standardized clinical indices, the modified Powell-Tuck index for UC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity 3</measure>
    <time_frame>2010-2014</time_frame>
    <description>Recent disease activity was measured with the Manitoba IBD Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Functioning 2</measure>
    <time_frame>2010-2014</time_frame>
    <description>The Cohen Perceived Stress Scale is a 14-item questionnaire, with a 5-point Likert response format, that assesses the individual's appraisal of their stress &quot;load&quot; related to chronic and acute stressors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Functioning 3</measure>
    <time_frame>2010-2014</time_frame>
    <description>The Brief Symptom Inventory is a well-established measure of current emotional distress related to multiple psychological symptoms, consisting of 53 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Functioning 4</measure>
    <time_frame>2010-2014</time_frame>
    <description>The Psychological Well-being Manifestations Scale consists of 25 items that query 6 general domains of positive experience using a 5-point Likert frequency scale, with higher scores indicating a greater sense of well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health and Quality of Life 2</measure>
    <time_frame>2010-2014</time_frame>
    <description>The 32-item Inflammatory Bowel Disease Questionnaire is a validated measure that has been extensively used in IBD studies to assess disease-specific quality of life.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">388</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Crohn Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Crohn's Disease Cohort</arm_group_label>
    <description>250 individuals in the Crohn's Disease Cohort</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ulcerative colitis cohort</arm_group_label>
    <description>108 individuals in the ulcerative colitis cohort</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Complete data were obtained in the first contact from 388 individuals. Over the first two&#xD;
        years of the longitudinal cohort study, there was a modest level of attrition and by the&#xD;
        time of the 24 month contact 353 respondents continued to participate.&#xD;
&#xD;
        The participating persons have been followed annually with in-person interviews and with&#xD;
        semi-annual mail-in surveys. By the end of 5 years 353 persons were still participating (a&#xD;
        loss of 1.8%/year).&#xD;
&#xD;
        Participants age was 18-83 and 60% are females. Approximately two thirds live in Winnipeg&#xD;
        and the rest live throughout Manitoba including Brandon, Dauphin, Swan River, Flin Flon,&#xD;
        Thompson, Winkler and Steinbach. Some subjects live elsewhere in Canada, yet still maintain&#xD;
        their participation.&#xD;
&#xD;
        270 subjects were followed until 2016&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed within the previous 7 years with Inflammatory Bowel Disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Bernstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mantioba</affiliation>
  </overall_official>
  <results_reference>
    <citation>Benchimol EI, Kaplan GG, Otley AR, Nguyen GC, Underwood FE, Guttmann A, Jones JL, Potter BK, Catley CA, Nugent ZJ, Cui Y, Tanyingoh D, Mojaverian N, Bitton A, Carroll MW, deBruyn J, Dummer TJB, El-Matary W, Griffiths AM, Jacobson K, Kuenzig ME, Leddin D, Lix LM, Mack DR, Murthy SK, Sanchez JNP, Singh H, Targownik LE, Vutcovici M, Bernstein CN. Rural and Urban Residence During Early Life is Associated with Risk of Inflammatory Bowel Disease: A Population-Based Inception and Birth Cohort Study. Am J Gastroenterol. 2017 Sep;112(9):1412-1422. doi: 10.1038/ajg.2017.208. Epub 2017 Jul 25. Erratum In: Am J Gastroenterol. 2017 Sep;112(9):1485.</citation>
    <PMID>28741616</PMID>
  </results_reference>
  <results_reference>
    <citation>Marrie RA, Sellers EAC, Chen H, Fransoo R, Bernstein CN, Hitchon CA, Peschken CA, Garland A. Markedly increased incidence of critical illness in adults with Type 1 diabetes. Diabet Med. 2017 Oct;34(10):1414-1420. doi: 10.1111/dme.13404. Epub 2017 Jul 12.</citation>
    <PMID>28626956</PMID>
  </results_reference>
  <results_reference>
    <citation>Restall GJ, Simms AM, Walker JR, Haviva C, Graff LA, Sexton KA, Miller N, Targownik LE, Bernstein CN. Coping with Inflammatory Bowel Disease: Engaging with Information to Inform Health-Related Decision Making in Daily Life. Inflamm Bowel Dis. 2017 Aug;23(8):1247-1256. doi: 10.1097/MIB.0000000000001141.</citation>
    <PMID>28498156</PMID>
  </results_reference>
  <results_reference>
    <citation>Singh H, Nugent Z, Yu BN, Lix LM, Targownik LE, Bernstein CN. Higher Incidence of Clostridium difficile Infection Among Individuals With Inflammatory Bowel Disease. Gastroenterology. 2017 Aug;153(2):430-438.e2. doi: 10.1053/j.gastro.2017.04.044. Epub 2017 May 4.</citation>
    <PMID>28479377</PMID>
  </results_reference>
  <results_reference>
    <citation>Benchimol EI, Bernstein CN, Bitton A, Carroll MW, Singh H, Otley AR, Vutcovici M, El-Matary W, Nguyen GC, Griffiths AM, Mack DR, Jacobson K, Mojaverian N, Tanyingoh D, Cui Y, Nugent ZJ, Coulombe J, Targownik LE, Jones JL, Leddin D, Murthy SK, Kaplan GG. Trends in Epidemiology of Pediatric Inflammatory Bowel Disease in Canada: Distributed Network Analysis of Multiple Population-Based Provincial Health Administrative Databases. Am J Gastroenterol. 2017 Jul;112(7):1120-1134. doi: 10.1038/ajg.2017.97. Epub 2017 Apr 18.</citation>
    <PMID>28417994</PMID>
  </results_reference>
  <results_reference>
    <citation>El-Matary W, Abej E, Deora V, Singh H, Bernstein CN. Impact of Fecal Calprotectin Measurement on Decision-making in Children with Inflammatory Bowel Disease. Front Pediatr. 2017 Jan 25;5:7. doi: 10.3389/fped.2017.00007. eCollection 2017.</citation>
    <PMID>28180127</PMID>
  </results_reference>
  <results_reference>
    <citation>Jewel Samadder N, Valentine JF, Guthery S, Singh H, Bernstein CN, Wan Y, Wong J, Boucher K, Pappas L, Rowe K, Bronner M, Ulrich CM, Burt RW, Curtin K, Smith KR. Colorectal Cancer in Inflammatory Bowel Diseases: A Population-Based Study in Utah. Dig Dis Sci. 2017 Aug;62(8):2126-2132. doi: 10.1007/s10620-016-4435-4. Epub 2017 Jan 3.</citation>
    <PMID>28050782</PMID>
  </results_reference>
  <results_reference>
    <citation>Nguyen GC, Bernstein CN, Benchimol EI. Risk of Surgery and Mortality in Elderly-onset Inflammatory Bowel Disease: A Population-based Cohort Study. Inflamm Bowel Dis. 2017 Feb;23(2):218-223. doi: 10.1097/MIB.0000000000000993.</citation>
    <PMID>27997435</PMID>
  </results_reference>
  <results_reference>
    <citation>Marrie RA, Walker JR, Graff LA, Lix LM, Bolton JM, Nugent Z, Targownik LE, Bernstein CN; CIHR Team &quot;Defining the burden and managing the effects of psychiatric comorbidity in chronic immunoinflammatory disease&quot;. Performance of administrative case definitions for depression and anxiety in inflammatory bowel disease. J Psychosom Res. 2016 Oct;89:107-13. doi: 10.1016/j.jpsychores.2016.08.014. Epub 2016 Sep 3.</citation>
    <PMID>27663119</PMID>
  </results_reference>
  <results_reference>
    <citation>Graff LA, Sexton KA, Walker JR, Clara I, Targownik LE, Bernstein CN. Validating a Measure of Patient Self-efficacy in Disease Self-management Using a Population-based IBD Cohort: The IBD Self-efficacy Scale. Inflamm Bowel Dis. 2016 Sep;22(9):2165-72. doi: 10.1097/MIB.0000000000000856.</citation>
    <PMID>27542132</PMID>
  </results_reference>
  <results_reference>
    <citation>Restall GJ, Simms AM, Walker JR, Graff LA, Sexton KA, Rogala L, Miller N, Haviva C, Targownik LE, Bernstein CN. Understanding Work Experiences of People with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Jul;22(7):1688-97. doi: 10.1097/MIB.0000000000000826.</citation>
    <PMID>27271487</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Marrie RA. Predictors of ICU Admission and Outcomes 1 Year Post-Admission in Persons with IBD: A Population-based Study. Inflamm Bowel Dis. 2015 Jun;21(6):1341-7. doi: 10.1097/MIB.0000000000000363.</citation>
    <PMID>25989339</PMID>
  </results_reference>
  <results_reference>
    <citation>Vagianos K, Clara I, Carr R, Graff LA, Walker JR, Targownik LE, Lix LM, Rogala L, Miller N, Bernstein CN. What Are Adults With Inflammatory Bowel Disease (IBD) Eating? A Closer Look at the Dietary Habits of a Population-Based Canadian IBD Cohort. JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):405-11. doi: 10.1177/0148607114549254. Epub 2014 Sep 4.</citation>
    <PMID>25189173</PMID>
  </results_reference>
  <results_reference>
    <citation>Serrano Leon A, Amir Shaghaghi M, Yurkova N, Bernstein CN, El-Gabalawy H, Eck P. Single-nucleotide polymorphisms in SLC22A23 are associated with ulcerative colitis in a Canadian white cohort. Am J Clin Nutr. 2014 Jul;100(1):289-94. doi: 10.3945/ajcn.113.080549. Epub 2014 Apr 16.</citation>
    <PMID>24740203</PMID>
  </results_reference>
  <results_reference>
    <citation>Marrie RA, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Bernstein CN. Increased incidence of critical illness among patients with inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2063-70.e1-4. doi: 10.1016/j.cgh.2014.03.033. Epub 2014 Apr 12.</citation>
    <PMID>24726908</PMID>
  </results_reference>
  <results_reference>
    <citation>Israeli E, Graff LA, Clara I, Walker JR, Lix LM, Targownik LE, Bernstein CN. Low prevalence of disability among patients with inflammatory bowel diseases a decade after diagnosis. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1330-7.e2. doi: 10.1016/j.cgh.2013.12.009. Epub 2013 Dec 17.</citation>
    <PMID>24361416</PMID>
  </results_reference>
  <results_reference>
    <citation>Amir Shaghaghi M, Bernstein CN, Serrano Leon A, El-Gabalawy H, Eck P. Polymorphisms in the sodium-dependent ascorbate transporter gene SLC23A1 are associated with susceptibility to Crohn disease. Am J Clin Nutr. 2014 Feb;99(2):378-83. doi: 10.3945/ajcn.113.068015. Epub 2013 Nov 27.</citation>
    <PMID>24284447</PMID>
  </results_reference>
  <results_reference>
    <citation>Goldenberg BA, Graff LA, Clara I, Zarychanski R, Walker JR, Carr R, Rogala L, Miller N, Bernstein CN. Is iron deficiency in the absence of anemia associated with fatigue in inflammatory bowel disease? Am J Gastroenterol. 2013 Sep;108(9):1392-7. doi: 10.1038/ajg.2013.14.</citation>
    <PMID>24005345</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Ryan JD, Graff LA, Xu W. Commentary: predicting complicated Crohn's disease and surgery--phenotypes, genetics, serology and psychological characteristics of a population-based cohort--authors' reply. Aliment Pharmacol Ther. 2013 Sep;38(5):556-7. doi: 10.1111/apt.12423. No abstract available.</citation>
    <PMID>23937465</PMID>
  </results_reference>
  <results_reference>
    <citation>Ryan JD, Silverberg MS, Xu W, Graff LA, Targownik LE, Walker JR, Carr R, Clara I, Miller N, Rogala L, Bernstein CN. Predicting complicated Crohn's disease and surgery: phenotypes, genetics, serology and psychological characteristics of a population-based cohort. Aliment Pharmacol Ther. 2013 Aug;38(3):274-83. doi: 10.1111/apt.12368. Epub 2013 Jun 3.</citation>
    <PMID>23725363</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Ng SC, Lakatos PL, Moum B, Loftus EV Jr; Epidemiology and Natural History Task Force of the International Organization of the Study of Inflammatory Bowel Disease. A review of mortality and surgery in ulcerative colitis: milestones of the seriousness of the disease. Inflamm Bowel Dis. 2013 Aug;19(9):2001-10. doi: 10.1097/MIB.0b013e318281f3bb.</citation>
    <PMID>23624887</PMID>
  </results_reference>
  <results_reference>
    <citation>Graff LA, Clara I, Walker JR, Lix L, Carr R, Miller N, Rogala L, Bernstein CN. Changes in fatigue over 2 years are associated with activity of inflammatory bowel disease and psychological factors. Clin Gastroenterol Hepatol. 2013 Sep;11(9):1140-6. doi: 10.1016/j.cgh.2013.03.031. Epub 2013 Apr 16.</citation>
    <PMID>23602816</PMID>
  </results_reference>
  <results_reference>
    <citation>Targownik LE, Leslie WD, Carr R, Clara I, Miller N, Rogala L, Graff LA, Walker JR, Bernstein CN. Longitudinal change in bone mineral density in a population-based cohort of patients with inflammatory bowel disease. Calcif Tissue Int. 2012 Nov;91(5):356-63. doi: 10.1007/s00223-012-9650-1. Epub 2012 Sep 16.</citation>
    <PMID>22983212</PMID>
  </results_reference>
  <results_reference>
    <citation>Wong S, Walker JR, Carr R, Graff LA, Clara I, Promislow S, Rogala L, Miller N, Rawsthorne P, Bernstein CN. The information needs and preferences of persons with longstanding inflammatory bowel disease. Can J Gastroenterol. 2012 Aug;26(8):525-31. doi: 10.1155/2012/735386.</citation>
    <PMID>22891177</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein MT, Graff LA, Targownik LE, Downing K, Shafer LA, Rawsthorne P, Bernstein CN, Avery L. Gastrointestinal symptoms before and during menses in women with IBD. Aliment Pharmacol Ther. 2012 Jul;36(2):135-44. doi: 10.1111/j.1365-2036.2012.05155.x. Epub 2012 May 24.</citation>
    <PMID>22621660</PMID>
  </results_reference>
  <results_reference>
    <citation>Targownik LE, Singh H, Nugent Z, Bernstein CN. The epidemiology of colectomy in ulcerative colitis: results from a population-based cohort. Am J Gastroenterol. 2012 Aug;107(8):1228-35. doi: 10.1038/ajg.2012.127. Epub 2012 May 22. Erratum In: Am J Gastroenterol. 2013 Jan;108(1):157.</citation>
    <PMID>22613902</PMID>
  </results_reference>
  <results_reference>
    <citation>Shaw SY, Blanchard JF, Bernstein CN. Association between the use of antibiotics and new diagnoses of Crohn's disease and ulcerative colitis. Am J Gastroenterol. 2011 Dec;106(12):2133-42. doi: 10.1038/ajg.2011.304. Epub 2011 Sep 13.</citation>
    <PMID>21912437</PMID>
  </results_reference>
  <results_reference>
    <citation>Rawsthorne P, Clara I, Graff LA, Bernstein KI, Carr R, Walker JR, Ediger J, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: a prospective longitudinal evaluation of the use of complementary and alternative medicine services and products. Gut. 2012 Apr;61(4):521-7. doi: 10.1136/gutjnl-2011-300219. Epub 2011 Aug 11.</citation>
    <PMID>21836028</PMID>
  </results_reference>
  <results_reference>
    <citation>Graff LA, Vincent N, Walker JR, Clara I, Carr R, Ediger J, Miller N, Rogala L, Rawsthorne P, Lix L, Bernstein CN. A population-based study of fatigue and sleep difficulties in inflammatory bowel disease. Inflamm Bowel Dis. 2011 Sep;17(9):1882-9. doi: 10.1002/ibd.21580. Epub 2010 Dec 22.</citation>
    <PMID>21830266</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, El-Gabalawy H, Sargent M, Landers C, Rawsthorne P, Elias B, Targan SR. Assessing inflammatory bowel disease-associated antibodies in Caucasian and First Nations cohorts. Can J Gastroenterol. 2011 May;25(5):269-73. doi: 10.1155/2011/712350.</citation>
    <PMID>21647462</PMID>
  </results_reference>
  <results_reference>
    <citation>Longobardi T, Walker JR, Graff LA, Bernstein CN. Health service utilization in IBD: comparison of self-report and administrative data. BMC Health Serv Res. 2011 May 31;11:137. doi: 10.1186/1472-6963-11-137.</citation>
    <PMID>21627808</PMID>
  </results_reference>
  <results_reference>
    <citation>Sajobi TT, Lix LM, Clara I, Walker J, Graff LA, Rawsthorne P, Miller N, Rogala L, Carr R, Bernstein CN. Measures of relative importance for health-related quality of life. Qual Life Res. 2012 Feb;21(1):1-11. doi: 10.1007/s11136-011-9914-7. Epub 2011 Apr 24.</citation>
    <PMID>21516478</PMID>
  </results_reference>
  <results_reference>
    <citation>Nguyen GC, Nugent Z, Shaw S, Bernstein CN. Outcomes of patients with Crohn's disease improved from 1988 to 2008 and were associated with increased specialist care. Gastroenterology. 2011 Jul;141(1):90-7. doi: 10.1053/j.gastro.2011.03.050. Epub 2011 Mar 31.</citation>
    <PMID>21458455</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Nugent Z, Blanchard JF. 5-aminosalicylate is not chemoprophylactic for colorectal cancer in IBD: a population based study. Am J Gastroenterol. 2011 Apr;106(4):731-6. doi: 10.1038/ajg.2011.50. Epub 2011 Mar 15.</citation>
    <PMID>21407180</PMID>
  </results_reference>
  <results_reference>
    <citation>Singh H, Nugent Z, Demers AA, Kliewer EV, Mahmud SM, Bernstein CN. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology. 2010 Oct;139(4):1128-37. doi: 10.1053/j.gastro.2010.06.052. Epub 2010 Jun 20.</citation>
    <PMID>20600026</PMID>
  </results_reference>
  <results_reference>
    <citation>Nugent Z, Blanchard JF, Bernstein CN. A population-based study of health-care resource use among infliximab users. Am J Gastroenterol. 2010 Sep;105(9):2009-16. doi: 10.1038/ajg.2010.139. Epub 2010 Apr 6.</citation>
    <PMID>20372114</PMID>
  </results_reference>
  <results_reference>
    <citation>Graff LA, Walker JR, Clara I, Lix L, Miller N, Rogala L, Rawsthorne P, Bernstein CN. Stress coping, distress, and health perceptions in inflammatory bowel disease and community controls. Am J Gastroenterol. 2009 Dec;104(12):2959-69. doi: 10.1038/ajg.2009.529. Epub 2009 Sep 15.</citation>
    <PMID>19755973</PMID>
  </results_reference>
  <results_reference>
    <citation>Clara I, Lix LM, Walker JR, Graff LA, Miller N, Rogala L, Rawsthorne P, Bernstein CN. The Manitoba IBD Index: evidence for a new and simple indicator of IBD activity. Am J Gastroenterol. 2009 Jul;104(7):1754-63. doi: 10.1038/ajg.2009.197. Epub 2009 May 19.</citation>
    <PMID>19455122</PMID>
  </results_reference>
  <results_reference>
    <citation>Singh S, Graff LA, Bernstein CN. Do NSAIDs, antibiotics, infections, or stress trigger flares in IBD? Am J Gastroenterol. 2009 May;104(5):1298-313; quiz 1314. doi: 10.1038/ajg.2009.15. Epub 2009 Mar 31.</citation>
    <PMID>19337242</PMID>
  </results_reference>
  <results_reference>
    <citation>Stainier DY, Bilder DH, Gilbert W. Spatial domains in the developing forebrain: developmental regulation of a restricted cell surface protein. Dev Biol. 1991 Sep;147(1):22-31. doi: 10.1016/s0012-1606(05)80004-1.</citation>
    <PMID>1879609</PMID>
  </results_reference>
  <results_reference>
    <citation>Leslie WD, Miller N, Rogala L, Bernstein CN. Body mass and composition affect bone density in recently diagnosed inflammatory bowel disease: the Manitoba IBD Cohort Study. Inflamm Bowel Dis. 2009 Jan;15(1):39-46. doi: 10.1002/ibd.20541.</citation>
    <PMID>18623166</PMID>
  </results_reference>
  <results_reference>
    <citation>Okazaki T, Wang MH, Rawsthorne P, Sargent M, Datta LW, Shugart YY, Bernstein CN, Brant SR. Contributions of IBD5, IL23R, ATG16L1, and NOD2 to Crohn's disease risk in a population-based case-control study: evidence of gene-gene interactions. Inflamm Bowel Dis. 2008 Nov;14(11):1528-41. doi: 10.1002/ibd.20512. Erratum In: Inflamm Bowel Dis. 2012 Aug;18(8):1591.</citation>
    <PMID>18521914</PMID>
  </results_reference>
  <results_reference>
    <citation>Lix LM, Graff LA, Walker JR, Clara I, Rawsthorne P, Rogala L, Miller N, Ediger J, Pretorius T, Bernstein CN. Longitudinal study of quality of life and psychological functioning for active, fluctuating, and inactive disease patterns in inflammatory bowel disease. Inflamm Bowel Dis. 2008 Nov;14(11):1575-84. doi: 10.1002/ibd.20511.</citation>
    <PMID>18512245</PMID>
  </results_reference>
  <results_reference>
    <citation>Leslie WD, Miller N, Rogala L, Bernstein CN. Vitamin D status and bone density in recently diagnosed inflammatory bowel disease: the Manitoba IBD Cohort Study. Am J Gastroenterol. 2008 Jun;103(6):1451-9. doi: 10.1111/j.1572-0241.2007.01753.x. Epub 2008 Apr 16.</citation>
    <PMID>18422819</PMID>
  </results_reference>
  <results_reference>
    <citation>Rogala L, Miller N, Graff LA, Rawsthorne P, Clara I, Walker JR, Lix L, Ediger JP, McPhail C, Bernstein CN. Population-based controlled study of social support, self-perceived stress, activity and work issues, and access to health care in inflammatory bowel disease. Inflamm Bowel Dis. 2008 Apr;14(4):526-35. doi: 10.1002/ibd.20353.</citation>
    <PMID>18183608</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Wajda A, Blanchard JF. The incidence of arterial thromboembolic diseases in inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2008 Jan;6(1):41-5. doi: 10.1016/j.cgh.2007.09.016. Epub 2007 Dec 11.</citation>
    <PMID>18063423</PMID>
  </results_reference>
  <results_reference>
    <citation>Ediger JP, Walker JR, Graff L, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, McPhail C, Deering K, Bernstein CN. Predictors of medication adherence in inflammatory bowel disease. Am J Gastroenterol. 2007 Jul;102(7):1417-26. doi: 10.1111/j.1572-0241.2007.01212.x. Epub 2007 Apr 16.</citation>
    <PMID>17437505</PMID>
  </results_reference>
  <results_reference>
    <citation>Graff LA, Walker JR, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, Jakul L, McPhail C, Ediger J, Bernstein CN. The relationship of inflammatory bowel disease type and activity to psychological functioning and quality of life. Clin Gastroenterol Hepatol. 2006 Dec;4(12):1491-1501. doi: 10.1016/j.cgh.2006.09.027.</citation>
    <PMID>17162241</PMID>
  </results_reference>
  <results_reference>
    <citation>Brant SR, Wang MH, Rawsthorne P, Sargent M, Datta LW, Nouvet F, Shugart YY, Bernstein CN. A population-based case-control study of CARD15 and other risk factors in Crohn's disease and ulcerative colitis. Am J Gastroenterol. 2007 Feb;102(2):313-23. doi: 10.1111/j.1572-0241.2006.00926.x. Epub 2006 Nov 13.</citation>
    <PMID>17100976</PMID>
  </results_reference>
  <results_reference>
    <citation>Tang LY, Rawsthorne P, Bernstein CN. Are perineal and luminal fistulas associated in Crohn's disease? A population-based study. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1130-4. doi: 10.1016/j.cgh.2006.06.021. Epub 2006 Aug 14.</citation>
    <PMID>16905369</PMID>
  </results_reference>
  <results_reference>
    <citation>Longobardi T, Bernstein CN. Health care resource utilization in inflammatory bowel disease. Clin Gastroenterol Hepatol. 2006 Jun;4(6):731-43. doi: 10.1016/j.cgh.2006.02.013. Epub 2006 May 2.</citation>
    <PMID>16631415</PMID>
  </results_reference>
  <results_reference>
    <citation>Burgmann T, Clara I, Graff L, Walker J, Lix L, Rawsthorne P, McPhail C, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: prolonged symptoms before diagnosis--how much is irritable bowel syndrome? Clin Gastroenterol Hepatol. 2006 May;4(5):614-20. doi: 10.1016/j.cgh.2006.03.003. Epub 2006 Apr 17.</citation>
    <PMID>16630762</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Wajda A, Blanchard JF. The clustering of other chronic inflammatory diseases in inflammatory bowel disease: a population-based study. Gastroenterology. 2005 Sep;129(3):827-36. doi: 10.1053/j.gastro.2005.06.021.</citation>
    <PMID>16143122</PMID>
  </results_reference>
  <results_reference>
    <citation>Goldenberg BA, Rawsthorne P, Bernstein CN. The utility of 6-thioguanine metabolite levels in managing patients with inflammatory bowel disease. Am J Gastroenterol. 2004 Sep;99(9):1744-8. doi: 10.1111/j.1572-0241.2004.30415.x.</citation>
    <PMID>15330913</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Bector S, Leslie WD. Lack of relationship of calcium and vitamin D intake to bone mineral density in premenopausal women with inflammatory bowel disease. Am J Gastroenterol. 2003 Nov;98(11):2468-73. doi: 10.1111/j.1572-0241.2003.07676.x.</citation>
    <PMID>14638350</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Leslie WD, Taback SP. Bone density in a population-based cohort of premenopausal adult women with early onset inflammatory bowel disease. Am J Gastroenterol. 2003 May;98(5):1094-100. doi: 10.1111/j.1572-0241.2003.07415.x.</citation>
    <PMID>12809833</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Blanchard JF, Rawsthorne P, Yu N. The prevalence of extraintestinal diseases in inflammatory bowel disease: a population-based study. Am J Gastroenterol. 2001 Apr;96(4):1116-22. doi: 10.1111/j.1572-0241.2001.03756.x.</citation>
    <PMID>11316157</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Blanchard JF, Houston DS, Wajda A. The incidence of deep venous thrombosis and pulmonary embolism among patients with inflammatory bowel disease: a population-based cohort study. Thromb Haemost. 2001 Mar;85(3):430-4.</citation>
    <PMID>11307809</PMID>
  </results_reference>
  <results_reference>
    <citation>Bernstein CN, Blanchard JF, Leslie W, Wajda A, Yu BN. The incidence of fracture among patients with inflammatory bowel disease. A population-based cohort study. Ann Intern Med. 2000 Nov 21;133(10):795-9. doi: 10.7326/0003-4819-133-10-200011210-00012.</citation>
    <PMID>11085842</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262649
org study id: REB#=HS14734 (H2002:040)
nct id: NCT03262649
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a
      population-based research registry.

      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline
      survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys
      and annually with interviews. Diagnosis and disease type were verified by chart review.
The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study, initiated in 2002, is study of
      adults with IBD who have been tracked prospectively through annual clinical interviews and
      semiannual surveys. The participants were drawn from a validated population-based research
      registry, which identified and recruited individuals using an administrative definition of
      IBD from the comprehensive health data base of Manitoba Health, the single insurer that
      provides health care to all residents in the province.

      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline
      survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys
      and annually with interviews. Diagnosis and disease type were verified by chart review. It
      has been demonstrated that the Cohort is representative of the provincial IBD population as a
      whole, with comparable age distribution, sex distribution, disease duration, and rural/urban
      residence.
observational model: Cohort
time perspective: Prospective
measure: Genetic Associations
time frame: 2010 to 2016
description: Single Nucleotide Variations (SNPs) in gene encoding for membrane transporter proteins were investigated for associations with both IBDs. Target genes included SLC23A1, SLC22A4, SLC22A5, SLC22A23, SLC2A14, SLC2A2 but analyses are not limited to these.
measure: Psychological Functioning 1
time frame: 2010-2014
description: The validated 7-item Mastery scale assesses the degree to which persons feel they have some control or mastery over their life to handle day-to-day challenges.
measure: Self Efficacy
time frame: 2010-2014
description: The IBD- Self Efficacy (SE) is a 29-item scale developed by Keefer et al. (1) based on patient interview, validated self-efficacy measures for other diseases. The instrument assesses the level of confidence in managing various disease-related "tasks," with item scores ranging from 1 (not at all) to 10 (totally), and higher scores reflecting greater disease self-management efficacy. Items were grouped conceptually into 4 subscales, reflecting domains identified by patients with IBD as important [1] managing stress and emotions (sample items: keep from feeling sad; do something to reduce stress); [2] managing medical care (sample items: take medication at instructed times; work out differences with doctors); [3] managing symptoms and disease (sample items: keep diarrhea/urgency from interfering; decrease fatigue); [4] maintaining remission (sample items: engage in self-care; maintain sense of well-being).
measure: Disability
time frame: 2010-2014
description: The Sheehan Disability Scale is a commonly used and validated instrument that measures disease interference in 3 primary domains of life: work, social, and home, based on a visual analog scale from 0 (no interference) to 10 (very severe interference). (1,2)
Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11(suppl 3):89-95.
Leon AC, Olfson M, Portera L, et al. Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiatry Med. 1997;27:93-105.
measure: Health and Quality of Life 1
time frame: 2010-2014
description: Perceived health was assessed using the General Health item from the Medical Outcome Survey Short Form 36, (1) which asks participants to characterize their health in the past year, using 5 response categories from "Excellent" to "Poor."
measure: Disease Activity 1
time frame: 2010-2014
description: Current disease activity was assessed using standardized clinical indices, the Harvey-Bradshaw index for CD.
measure: Disease Activity 2
time frame: 2010-2014
description: Current disease activity was assessed using standardized clinical indices, the modified Powell-Tuck index for UC.
measure: Disease Activity 3
time frame: 2010-2014
description: Recent disease activity was measured with the Manitoba IBD Index
measure: Psychological Functioning 2
time frame: 2010-2014
description: The Cohen Perceived Stress Scale is a 14-item questionnaire, with a 5-point Likert response format, that assesses the individual's appraisal of their stress "load" related to chronic and acute stressors.
measure: Psychological Functioning 3
time frame: 2010-2014
description: The Brief Symptom Inventory is a well-established measure of current emotional distress related to multiple psychological symptoms, consisting of 53 items.
measure: Psychological Functioning 4
time frame: 2010-2014
description: The Psychological Well-being Manifestations Scale consists of 25 items that query 6 general domains of positive experience using a 5-point Likert frequency scale, with higher scores indicating a greater sense of well-being.
measure: Health and Quality of Life 2
time frame: 2010-2014
description: The 32-item Inflammatory Bowel Disease Questionnaire is a validated measure that has been extensively used in IBD studies to assess disease-specific quality of life.
arm group label: Crohn's Disease Cohort
description: 250 individuals in the Crohn's Disease Cohort
arm group label: ulcerative colitis cohort
description: 108 individuals in the ulcerative colitis cohort
Plasma, DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Charles Bernstein, MD
role: Principal Investigator
affiliation: University of Mantioba
citation: Benchimol EI, Kaplan GG, Otley AR, Nguyen GC, Underwood FE, Guttmann A, Jones JL, Potter BK, Catley CA, Nugent ZJ, Cui Y, Tanyingoh D, Mojaverian N, Bitton A, Carroll MW, deBruyn J, Dummer TJB, El-Matary W, Griffiths AM, Jacobson K, Kuenzig ME, Leddin D, Lix LM, Mack DR, Murthy SK, Sanchez JNP, Singh H, Targownik LE, Vutcovici M, Bernstein CN. Rural and Urban Residence During Early Life is Associated with Risk of Inflammatory Bowel Disease: A Population-Based Inception and Birth Cohort Study. Am J Gastroenterol. 2017 Sep;112(9):1412-1422. doi: 10.1038/ajg.2017.208. Epub 2017 Jul 25. Erratum In: Am J Gastroenterol. 2017 Sep;112(9):1485.
PMID: 28741616
citation: Marrie RA, Sellers EAC, Chen H, Fransoo R, Bernstein CN, Hitchon CA, Peschken CA, Garland A. Markedly increased incidence of critical illness in adults with Type 1 diabetes. Diabet Med. 2017 Oct;34(10):1414-1420. doi: 10.1111/dme.13404. Epub 2017 Jul 12.
PMID: 28626956
citation: Restall GJ, Simms AM, Walker JR, Haviva C, Graff LA, Sexton KA, Miller N, Targownik LE, Bernstein CN. Coping with Inflammatory Bowel Disease: Engaging with Information to Inform Health-Related Decision Making in Daily Life. Inflamm Bowel Dis. 2017 Aug;23(8):1247-1256. doi: 10.1097/MIB.0000000000001141.
PMID: 28498156
citation: Singh H, Nugent Z, Yu BN, Lix LM, Targownik LE, Bernstein CN. Higher Incidence of Clostridium difficile Infection Among Individuals With Inflammatory Bowel Disease. Gastroenterology. 2017 Aug;153(2):430-438.e2. doi: 10.1053/j.gastro.2017.04.044. Epub 2017 May 4.
PMID: 28479377
citation: Benchimol EI, Bernstein CN, Bitton A, Carroll MW, Singh H, Otley AR, Vutcovici M, El-Matary W, Nguyen GC, Griffiths AM, Mack DR, Jacobson K, Mojaverian N, Tanyingoh D, Cui Y, Nugent ZJ, Coulombe J, Targownik LE, Jones JL, Leddin D, Murthy SK, Kaplan GG. Trends in Epidemiology of Pediatric Inflammatory Bowel Disease in Canada: Distributed Network Analysis of Multiple Population-Based Provincial Health Administrative Databases. Am J Gastroenterol. 2017 Jul;112(7):1120-1134. doi: 10.1038/ajg.2017.97. Epub 2017 Apr 18.
PMID: 28417994
citation: El-Matary W, Abej E, Deora V, Singh H, Bernstein CN. Impact of Fecal Calprotectin Measurement on Decision-making in Children with Inflammatory Bowel Disease. Front Pediatr. 2017 Jan 25;5:7. doi: 10.3389/fped.2017.00007. eCollection 2017.
PMID: 28180127
citation: Jewel Samadder N, Valentine JF, Guthery S, Singh H, Bernstein CN, Wan Y, Wong J, Boucher K, Pappas L, Rowe K, Bronner M, Ulrich CM, Burt RW, Curtin K, Smith KR. Colorectal Cancer in Inflammatory Bowel Diseases: A Population-Based Study in Utah. Dig Dis Sci. 2017 Aug;62(8):2126-2132. doi: 10.1007/s10620-016-4435-4. Epub 2017 Jan 3.
PMID: 28050782
citation: Nguyen GC, Bernstein CN, Benchimol EI. Risk of Surgery and Mortality in Elderly-onset Inflammatory Bowel Disease: A Population-based Cohort Study. Inflamm Bowel Dis. 2017 Feb;23(2):218-223. doi: 10.1097/MIB.0000000000000993.
PMID: 27997435
citation: Marrie RA, Walker JR, Graff LA, Lix LM, Bolton JM, Nugent Z, Targownik LE, Bernstein CN; CIHR Team "Defining the burden and managing the effects of psychiatric comorbidity in chronic immunoinflammatory disease". Performance of administrative case definitions for depression and anxiety in inflammatory bowel disease. J Psychosom Res. 2016 Oct;89:107-13. doi: 10.1016/j.jpsychores.2016.08.014. Epub 2016 Sep 3.
PMID: 27663119
citation: Graff LA, Sexton KA, Walker JR, Clara I, Targownik LE, Bernstein CN. Validating a Measure of Patient Self-efficacy in Disease Self-management Using a Population-based IBD Cohort: The IBD Self-efficacy Scale. Inflamm Bowel Dis. 2016 Sep;22(9):2165-72. doi: 10.1097/MIB.0000000000000856.
PMID: 27542132
citation: Restall GJ, Simms AM, Walker JR, Graff LA, Sexton KA, Rogala L, Miller N, Haviva C, Targownik LE, Bernstein CN. Understanding Work Experiences of People with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Jul;22(7):1688-97. doi: 10.1097/MIB.0000000000000826.
PMID: 27271487
citation: Bernstein CN, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Marrie RA. Predictors of ICU Admission and Outcomes 1 Year Post-Admission in Persons with IBD: A Population-based Study. Inflamm Bowel Dis. 2015 Jun;21(6):1341-7. doi: 10.1097/MIB.0000000000000363.
PMID: 25989339
citation: Vagianos K, Clara I, Carr R, Graff LA, Walker JR, Targownik LE, Lix LM, Rogala L, Miller N, Bernstein CN. What Are Adults With Inflammatory Bowel Disease (IBD) Eating? A Closer Look at the Dietary Habits of a Population-Based Canadian IBD Cohort. JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):405-11. doi: 10.1177/0148607114549254. Epub 2014 Sep 4.
PMID: 25189173
citation: Serrano Leon A, Amir Shaghaghi M, Yurkova N, Bernstein CN, El-Gabalawy H, Eck P. Single-nucleotide polymorphisms in SLC22A23 are associated with ulcerative colitis in a Canadian white cohort. Am J Clin Nutr. 2014 Jul;100(1):289-94. doi: 10.3945/ajcn.113.080549. Epub 2014 Apr 16.
PMID: 24740203
citation: Marrie RA, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Bernstein CN. Increased incidence of critical illness among patients with inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2063-70.e1-4. doi: 10.1016/j.cgh.2014.03.033. Epub 2014 Apr 12.
PMID: 24726908
citation: Israeli E, Graff LA, Clara I, Walker JR, Lix LM, Targownik LE, Bernstein CN. Low prevalence of disability among patients with inflammatory bowel diseases a decade after diagnosis. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1330-7.e2. doi: 10.1016/j.cgh.2013.12.009. Epub 2013 Dec 17.
PMID: 24361416
citation: Amir Shaghaghi M, Bernstein CN, Serrano Leon A, El-Gabalawy H, Eck P. Polymorphisms in the sodium-dependent ascorbate transporter gene SLC23A1 are associated with susceptibility to Crohn disease. Am J Clin Nutr. 2014 Feb;99(2):378-83. doi: 10.3945/ajcn.113.068015. Epub 2013 Nov 27.
PMID: 24284447
citation: Goldenberg BA, Graff LA, Clara I, Zarychanski R, Walker JR, Carr R, Rogala L, Miller N, Bernstein CN. Is iron deficiency in the absence of anemia associated with fatigue in inflammatory bowel disease? Am J Gastroenterol. 2013 Sep;108(9):1392-7. doi: 10.1038/ajg.2013.14.
PMID: 24005345
citation: Bernstein CN, Ryan JD, Graff LA, Xu W. Commentary: predicting complicated Crohn's disease and surgery--phenotypes, genetics, serology and psychological characteristics of a population-based cohort--authors' reply. Aliment Pharmacol Ther. 2013 Sep;38(5):556-7. doi: 10.1111/apt.12423. No abstract available.
PMID: 23937465
citation: Ryan JD, Silverberg MS, Xu W, Graff LA, Targownik LE, Walker JR, Carr R, Clara I, Miller N, Rogala L, Bernstein CN. Predicting complicated Crohn's disease and surgery: phenotypes, genetics, serology and psychological characteristics of a population-based cohort. Aliment Pharmacol Ther. 2013 Aug;38(3):274-83. doi: 10.1111/apt.12368. Epub 2013 Jun 3.
PMID: 23725363
citation: Bernstein CN, Ng SC, Lakatos PL, Moum B, Loftus EV Jr; Epidemiology and Natural History Task Force of the International Organization of the Study of Inflammatory Bowel Disease. A review of mortality and surgery in ulcerative colitis: milestones of the seriousness of the disease. Inflamm Bowel Dis. 2013 Aug;19(9):2001-10. doi: 10.1097/MIB.0b013e318281f3bb.
PMID: 23624887
citation: Graff LA, Clara I, Walker JR, Lix L, Carr R, Miller N, Rogala L, Bernstein CN. Changes in fatigue over 2 years are associated with activity of inflammatory bowel disease and psychological factors. Clin Gastroenterol Hepatol. 2013 Sep;11(9):1140-6. doi: 10.1016/j.cgh.2013.03.031. Epub 2013 Apr 16.
PMID: 23602816
citation: Targownik LE, Leslie WD, Carr R, Clara I, Miller N, Rogala L, Graff LA, Walker JR, Bernstein CN. Longitudinal change in bone mineral density in a population-based cohort of patients with inflammatory bowel disease. Calcif Tissue Int. 2012 Nov;91(5):356-63. doi: 10.1007/s00223-012-9650-1. Epub 2012 Sep 16.
PMID: 22983212
citation: Wong S, Walker JR, Carr R, Graff LA, Clara I, Promislow S, Rogala L, Miller N, Rawsthorne P, Bernstein CN. The information needs and preferences of persons with longstanding inflammatory bowel disease. Can J Gastroenterol. 2012 Aug;26(8):525-31. doi: 10.1155/2012/735386.
PMID: 22891177
citation: Bernstein MT, Graff LA, Targownik LE, Downing K, Shafer LA, Rawsthorne P, Bernstein CN, Avery L. Gastrointestinal symptoms before and during menses in women with IBD. Aliment Pharmacol Ther. 2012 Jul;36(2):135-44. doi: 10.1111/j.1365-2036.2012.05155.x. Epub 2012 May 24.
PMID: 22621660
citation: Targownik LE, Singh H, Nugent Z, Bernstein CN. The epidemiology of colectomy in ulcerative colitis: results from a population-based cohort. Am J Gastroenterol. 2012 Aug;107(8):1228-35. doi: 10.1038/ajg.2012.127. Epub 2012 May 22. Erratum In: Am J Gastroenterol. 2013 Jan;108(1):157.
PMID: 22613902
citation: Shaw SY, Blanchard JF, Bernstein CN. Association between the use of antibiotics and new diagnoses of Crohn's disease and ulcerative colitis. Am J Gastroenterol. 2011 Dec;106(12):2133-42. doi: 10.1038/ajg.2011.304. Epub 2011 Sep 13.
PMID: 21912437
citation: Rawsthorne P, Clara I, Graff LA, Bernstein KI, Carr R, Walker JR, Ediger J, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: a prospective longitudinal evaluation of the use of complementary and alternative medicine services and products. Gut. 2012 Apr;61(4):521-7. doi: 10.1136/gutjnl-2011-300219. Epub 2011 Aug 11.
PMID: 21836028
citation: Graff LA, Vincent N, Walker JR, Clara I, Carr R, Ediger J, Miller N, Rogala L, Rawsthorne P, Lix L, Bernstein CN. A population-based study of fatigue and sleep difficulties in inflammatory bowel disease. Inflamm Bowel Dis. 2011 Sep;17(9):1882-9. doi: 10.1002/ibd.21580. Epub 2010 Dec 22.
PMID: 21830266
citation: Bernstein CN, El-Gabalawy H, Sargent M, Landers C, Rawsthorne P, Elias B, Targan SR. Assessing inflammatory bowel disease-associated antibodies in Caucasian and First Nations cohorts. Can J Gastroenterol. 2011 May;25(5):269-73. doi: 10.1155/2011/712350.
PMID: 21647462
citation: Longobardi T, Walker JR, Graff LA, Bernstein CN. Health service utilization in IBD: comparison of self-report and administrative data. BMC Health Serv Res. 2011 May 31;11:137. doi: 10.1186/1472-6963-11-137.
PMID: 21627808
citation: Sajobi TT, Lix LM, Clara I, Walker J, Graff LA, Rawsthorne P, Miller N, Rogala L, Carr R, Bernstein CN. Measures of relative importance for health-related quality of life. Qual Life Res. 2012 Feb;21(1):1-11. doi: 10.1007/s11136-011-9914-7. Epub 2011 Apr 24.
PMID: 21516478
citation: Nguyen GC, Nugent Z, Shaw S, Bernstein CN. Outcomes of patients with Crohn's disease improved from 1988 to 2008 and were associated with increased specialist care. Gastroenterology. 2011 Jul;141(1):90-7. doi: 10.1053/j.gastro.2011.03.050. Epub 2011 Mar 31.
PMID: 21458455
citation: Bernstein CN, Nugent Z, Blanchard JF. 5-aminosalicylate is not chemoprophylactic for colorectal cancer in IBD: a population based study. Am J Gastroenterol. 2011 Apr;106(4):731-6. doi: 10.1038/ajg.2011.50. Epub 2011 Mar 15.
PMID: 21407180
citation: Singh H, Nugent Z, Demers AA, Kliewer EV, Mahmud SM, Bernstein CN. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology. 2010 Oct;139(4):1128-37. doi: 10.1053/j.gastro.2010.06.052. Epub 2010 Jun 20.
PMID: 20600026
citation: Nugent Z, Blanchard JF, Bernstein CN. A population-based study of health-care resource use among infliximab users. Am J Gastroenterol. 2010 Sep;105(9):2009-16. doi: 10.1038/ajg.2010.139. Epub 2010 Apr 6.
PMID: 20372114
citation: Graff LA, Walker JR, Clara I, Lix L, Miller N, Rogala L, Rawsthorne P, Bernstein CN. Stress coping, distress, and health perceptions in inflammatory bowel disease and community controls. Am J Gastroenterol. 2009 Dec;104(12):2959-69. doi: 10.1038/ajg.2009.529. Epub 2009 Sep 15.
PMID: 19755973
citation: Clara I, Lix LM, Walker JR, Graff LA, Miller N, Rogala L, Rawsthorne P, Bernstein CN. The Manitoba IBD Index: evidence for a new and simple indicator of IBD activity. Am J Gastroenterol. 2009 Jul;104(7):1754-63. doi: 10.1038/ajg.2009.197. Epub 2009 May 19.
PMID: 19455122
citation: Singh S, Graff LA, Bernstein CN. Do NSAIDs, antibiotics, infections, or stress trigger flares in IBD? Am J Gastroenterol. 2009 May;104(5):1298-313; quiz 1314. doi: 10.1038/ajg.2009.15. Epub 2009 Mar 31.
PMID: 19337242
citation: Stainier DY, Bilder DH, Gilbert W. Spatial domains in the developing forebrain: developmental regulation of a restricted cell surface protein. Dev Biol. 1991 Sep;147(1):22-31. doi: 10.1016/s0012-1606(05)80004-1.
PMID: 1879609
citation: Leslie WD, Miller N, Rogala L, Bernstein CN. Body mass and composition affect bone density in recently diagnosed inflammatory bowel disease: the Manitoba IBD Cohort Study. Inflamm Bowel Dis. 2009 Jan;15(1):39-46. doi: 10.1002/ibd.20541.
PMID: 18623166
citation: Okazaki T, Wang MH, Rawsthorne P, Sargent M, Datta LW, Shugart YY, Bernstein CN, Brant SR. Contributions of IBD5, IL23R, ATG16L1, and NOD2 to Crohn's disease risk in a population-based case-control study: evidence of gene-gene interactions. Inflamm Bowel Dis. 2008 Nov;14(11):1528-41. doi: 10.1002/ibd.20512. Erratum In: Inflamm Bowel Dis. 2012 Aug;18(8):1591.
PMID: 18521914
citation: Lix LM, Graff LA, Walker JR, Clara I, Rawsthorne P, Rogala L, Miller N, Ediger J, Pretorius T, Bernstein CN. Longitudinal study of quality of life and psychological functioning for active, fluctuating, and inactive disease patterns in inflammatory bowel disease. Inflamm Bowel Dis. 2008 Nov;14(11):1575-84. doi: 10.1002/ibd.20511.
PMID: 18512245
citation: Leslie WD, Miller N, Rogala L, Bernstein CN. Vitamin D status and bone density in recently diagnosed inflammatory bowel disease: the Manitoba IBD Cohort Study. Am J Gastroenterol. 2008 Jun;103(6):1451-9. doi: 10.1111/j.1572-0241.2007.01753.x. Epub 2008 Apr 16.
PMID: 18422819
citation: Rogala L, Miller N, Graff LA, Rawsthorne P, Clara I, Walker JR, Lix L, Ediger JP, McPhail C, Bernstein CN. Population-based controlled study of social support, self-perceived stress, activity and work issues, and access to health care in inflammatory bowel disease. Inflamm Bowel Dis. 2008 Apr;14(4):526-35. doi: 10.1002/ibd.20353.
PMID: 18183608
citation: Bernstein CN, Wajda A, Blanchard JF. The incidence of arterial thromboembolic diseases in inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2008 Jan;6(1):41-5. doi: 10.1016/j.cgh.2007.09.016. Epub 2007 Dec 11.
PMID: 18063423
citation: Ediger JP, Walker JR, Graff L, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, McPhail C, Deering K, Bernstein CN. Predictors of medication adherence in inflammatory bowel disease. Am J Gastroenterol. 2007 Jul;102(7):1417-26. doi: 10.1111/j.1572-0241.2007.01212.x. Epub 2007 Apr 16.
PMID: 17437505
citation: Graff LA, Walker JR, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, Jakul L, McPhail C, Ediger J, Bernstein CN. The relationship of inflammatory bowel disease type and activity to psychological functioning and quality of life. Clin Gastroenterol Hepatol. 2006 Dec;4(12):1491-1501. doi: 10.1016/j.cgh.2006.09.027.
PMID: 17162241
citation: Brant SR, Wang MH, Rawsthorne P, Sargent M, Datta LW, Nouvet F, Shugart YY, Bernstein CN. A population-based case-control study of CARD15 and other risk factors in Crohn's disease and ulcerative colitis. Am J Gastroenterol. 2007 Feb;102(2):313-23. doi: 10.1111/j.1572-0241.2006.00926.x. Epub 2006 Nov 13.
PMID: 17100976
citation: Tang LY, Rawsthorne P, Bernstein CN. Are perineal and luminal fistulas associated in Crohn's disease? A population-based study. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1130-4. doi: 10.1016/j.cgh.2006.06.021. Epub 2006 Aug 14.
PMID: 16905369
citation: Longobardi T, Bernstein CN. Health care resource utilization in inflammatory bowel disease. Clin Gastroenterol Hepatol. 2006 Jun;4(6):731-43. doi: 10.1016/j.cgh.2006.02.013. Epub 2006 May 2.
PMID: 16631415
citation: Burgmann T, Clara I, Graff L, Walker J, Lix L, Rawsthorne P, McPhail C, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: prolonged symptoms before diagnosis--how much is irritable bowel syndrome? Clin Gastroenterol Hepatol. 2006 May;4(5):614-20. doi: 10.1016/j.cgh.2006.03.003. Epub 2006 Apr 17.
PMID: 16630762
citation: Bernstein CN, Wajda A, Blanchard JF. The clustering of other chronic inflammatory diseases in inflammatory bowel disease: a population-based study. Gastroenterology. 2005 Sep;129(3):827-36. doi: 10.1053/j.gastro.2005.06.021.
PMID: 16143122
citation: Goldenberg BA, Rawsthorne P, Bernstein CN. The utility of 6-thioguanine metabolite levels in managing patients with inflammatory bowel disease. Am J Gastroenterol. 2004 Sep;99(9):1744-8. doi: 10.1111/j.1572-0241.2004.30415.x.
PMID: 15330913
citation: Bernstein CN, Bector S, Leslie WD. Lack of relationship of calcium and vitamin D intake to bone mineral density in premenopausal women with inflammatory bowel disease. Am J Gastroenterol. 2003 Nov;98(11):2468-73. doi: 10.1111/j.1572-0241.2003.07676.x.
PMID: 14638350
citation: Bernstein CN, Leslie WD, Taback SP. Bone density in a population-based cohort of premenopausal adult women with early onset inflammatory bowel disease. Am J Gastroenterol. 2003 May;98(5):1094-100. doi: 10.1111/j.1572-0241.2003.07415.x.
PMID: 12809833
citation: Bernstein CN, Blanchard JF, Rawsthorne P, Yu N. The prevalence of extraintestinal diseases in inflammatory bowel disease: a population-based study. Am J Gastroenterol. 2001 Apr;96(4):1116-22. doi: 10.1111/j.1572-0241.2001.03756.x.
PMID: 11316157
citation: Bernstein CN, Blanchard JF, Houston DS, Wajda A. The incidence of deep venous thrombosis and pulmonary embolism among patients with inflammatory bowel disease: a population-based cohort study. Thromb Haemost. 2001 Mar;85(3):430-4.
PMID: 11307809
citation: Bernstein CN, Blanchard JF, Leslie W, Wajda A, Yu BN. The incidence of fracture among patients with inflammatory bowel disease. A population-based cohort study. Ann Intern Med. 2000 Nov 21;133(10):795-9. doi: 10.7326/0003-4819-133-10-200011210-00012.
PMID: 11085842
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No