<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/NCT02193750</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01420</org_study_id>
    <nct_id>NCT02193750</nct_id>
  </id_info>
  <brief_title>Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease</brief_title>
  <official_title>Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Melbourne Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that a novel method for oligosaccharide supplementation, in the&#xD;
      form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS),&#xD;
      will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD)&#xD;
      in remission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects age &gt;/= 19 years with the diagnosis of CD for &gt;/= 6 months, currently in remission&#xD;
      based on the Harvey-Bradshaw Index score (&lt;/=4 points) and C-reactive protein (&lt;5 mg/L) will&#xD;
      be recruited from two academic hospitals and affiliated gastroenterology outpatient clinics&#xD;
      (St. Paul's Hospital, Vancouver, British Columbia, Canada; Alfred Hospital, Melbourne,&#xD;
      Victoria, Australia).&#xD;
&#xD;
      The study is a randomized, double-blind, placebo-controlled trial that consist of a 2-week&#xD;
      run-in period followed by a 4-week study period. Prior to study entry, a screening visit will&#xD;
      be required for all potential participants. If a participant meets the inclusion criteria,&#xD;
      they will be randomized to either a placebo (0.55 g total fructans/GOS), a moderate&#xD;
      oligosaccharide group (3.25 g total fructans/GOS) or a high oligosaccharide group (5.43 g&#xD;
      total fructans/GOS) through a computed-generated scheme within each respective center. During&#xD;
      the run-in period, enrolled subjects will undergo the following: 1) Laboratory analyses (CBC,&#xD;
      routine biochemistry, CRP and fecal calprotectin); 2) Stool collection for fecal calprotectin&#xD;
      analysis; 3) tolerability assessment including overall gastrointestinal symptoms and specific&#xD;
      symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) utilizing a 100mm&#xD;
      visual analogue scale (VAS, 0 = no symptoms; 100 = worst symptoms ever experienced); 4)&#xD;
      fatigue assessment utilizing a multi-dimensional fatigue impact scale (FIS); 5)&#xD;
      health-related quality of life (HRQOL) assessment utilizing the Short Form 36-Item Health&#xD;
      Survey (SF-36) and 6) Mood assessment utilizing the Spielberger State-Trait Personality&#xD;
      Inventory (STPI). Participants will also meet with a registered dietitian to quantify&#xD;
      baseline oligosaccharide consumption by completing a prospective 5-day diet diary alongside a&#xD;
      validated food frequency questionnaire (FFQ), the Monash University Comprehensive Nutritional&#xD;
      Assessment Questionnaire (CNAQ) that assesses oligosaccharide intake in addition to the usual&#xD;
      nutrients [49]. Once the initial dietary assessment is complete, participants will begin&#xD;
      up-titration of their oligosaccharide supplementation in a step-wise fashion until they reach&#xD;
      their required daily amounts defined by their treatment group allocation. Once this is&#xD;
      achieved, they will enter the 4 weeks of treatment or at time of relapse. Participants will&#xD;
      undergo re-assessment during the study period at 2 weeks (Visit #3), and at study completion&#xD;
      (Visit #4).&#xD;
&#xD;
      If a participant undergoes a CD flare during the run-in period, they will be withdrawn from&#xD;
      the study. The end point of the study will be at 4 weeks of treatment or at time of relapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The team decided to close this study since we are not recruiting and collecting any data.&#xD;
  </why_stopped>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">September 2020</completion_date>
  <primary_completion_date type="Actual">September 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in overall GI symptoms</measure>
    <time_frame>5 days</time_frame>
    <description>The primary outcome will be the difference in overall gastrointestinal symptoms quantified by the VAS, at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability assessment including overall gastrointestinal symptoms and specific symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>Secondary outcomes concerning tolerability will include differences in the individual gastrointestinal symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) quantified by the VAS at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Secondary endpoints concerning differences in the scores of the overall FIS (fatigue impact scale) and sub-categories (physical, cognitive, psychosocial) at study completion compared to baseline in all 3 study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Secondary endpoints concerning differences in physical components summary (PCS) and the mental component summary (MSC) scores at study completion compared to baseline in all 3 study groups respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Secondary endpoints concerning mood that will include differences in state anxiety, state curiosity, state anger, and state depression scores of the STPI at study completion compared to baseline in all 3 study groups respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Asessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>The proportion of participants who relapse, as well as the time to relapse at study completion between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence Assessment</measure>
    <time_frame>4 weeks</time_frame>
    <description>Adherence will be estimated and compared between groups at study completion</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 placebo muesli bars and 1 serving placebo muesli per day (0.55 g total fructans/GOS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Oligosaccharide Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Oligosaccharide Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 intervention muesli bar and 1 serving intervention muesli per day (5.43 total fructans/GOS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Moderate Oligosaccharide Group</intervention_name>
    <description>1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)</description>
    <arm_group_label>Moderate Oligosaccharide Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High Oligosaccharide Group</intervention_name>
    <description>1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)</description>
    <arm_group_label>High Oligosaccharide Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;/= 19 years&#xD;
&#xD;
          -  diagnosed with CD for &gt;/= 6 months, currently in remission based on the&#xD;
             Harvey-Bradshaw Index score (&lt;/= 4 points) and C-reactive protein (&lt;5mg/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to provide informed consent;&#xD;
&#xD;
          -  have significant hepatic, renal, endocrine, respiratory, neurological, or&#xD;
             cardiovascular disease;&#xD;
&#xD;
          -  confirmed diagnosis of celiac disease, or have suspected celiac disease and are&#xD;
             following a gluten-free diet to manage symptoms with an elevated screening anti-tissue&#xD;
             transglutaminase antibody test;&#xD;
&#xD;
          -  significant complications of CD which includes a history of extensive colonic&#xD;
             resection, including subtotal or total colectomy, history of &gt;/= 3 small bowel&#xD;
             resections or received a diagnosis of short bowel syndrome, current ileostomy,&#xD;
             colostomy or ileal-anal pouch, or a fixed symptomatic intestinal stenosis;&#xD;
&#xD;
          -  antibiotic use in the 4 weeks prior to study start;&#xD;
&#xD;
          -  use of any rectal preparations in the 2 weeks prior to study start;&#xD;
&#xD;
          -  use of any non-steroidal anti-inflammatory drugs in the 2 weeks prior to study start;&#xD;
&#xD;
          -  use of commercial probiotic supplements in the 4 weeks prior to study start&#xD;
&#xD;
          -  change in CD therapy in the 4 weeks prior to study start (excluding steroid taper,&#xD;
             however steroid dosing must be stable for 2 weeks prior to study start);&#xD;
&#xD;
          -  recently been adhering to a novel dietary intervention for alternative health issues&#xD;
             within the last 4 weeks prior to study start.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Bressler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Gibson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Gastroenterology Alfred Hospital, Melbourne, Australia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Clinic, St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Talley NJ, Abreu MT, Achkar JP, Bernstein CN, Dubinsky MC, Hanauer SB, Kane SV, Sandborn WJ, Ullman TA, Moayyedi P; American College of Gastroenterology IBD Task Force. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011 Apr;106 Suppl 1:S2-25; quiz S26. doi: 10.1038/ajg.2011.58. No abstract available.</citation>
    <PMID>21472012</PMID>
  </reference>
  <results_reference>
    <citation>Kappelman MD, Rifas-Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, Finkelstein JA. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1424-9. doi: 10.1016/j.cgh.2007.07.012. Epub 2007 Sep 29.</citation>
    <PMID>17904915</PMID>
  </results_reference>
  <results_reference>
    <citation>Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x.</citation>
    <PMID>18796097</PMID>
  </results_reference>
  <results_reference>
    <citation>Lichtenstein GR, Hanauer SB, Sandborn WJ; Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009 Feb;104(2):465-83; quiz 464, 484. doi: 10.1038/ajg.2008.168. Epub 2009 Jan 6.</citation>
    <PMID>19174807</PMID>
  </results_reference>
  <results_reference>
    <citation>Pai CG, Khandige GK. Is Crohn's disease rare in India? Indian J Gastroenterol. 2000 Jan-Mar;19(1):17-20.</citation>
    <PMID>10659482</PMID>
  </results_reference>
  <results_reference>
    <citation>El Mouzan MI, Abdullah AM, Al Habbal MT. Epidemiology of juvenile-onset inflammatory bowel disease in central Saudi Arabia. J Trop Pediatr. 2006 Feb;52(1):69-71. doi: 10.1093/tropej/fmi039. Epub 2005 Jun 9.</citation>
    <PMID>15947013</PMID>
  </results_reference>
  <results_reference>
    <citation>Ouyang Q, Tandon R, Goh KL, Ooi CJ, Ogata H, Fiocchi C. The emergence of inflammatory bowel disease in the Asian Pacific region. Curr Opin Gastroenterol. 2005 Jul;21(4):408-13.</citation>
    <PMID>15930979</PMID>
  </results_reference>
  <results_reference>
    <citation>Aghazadeh R, Zali MR, Bahari A, Amin K, Ghahghaie F, Firouzi F. Inflammatory bowel disease in Iran: a review of 457 cases. J Gastroenterol Hepatol. 2005 Nov;20(11):1691-5. doi: 10.1111/j.1440-1746.2005.03905.x.</citation>
    <PMID>16246187</PMID>
  </results_reference>
  <results_reference>
    <citation>Wright JP, Froggatt J, O'Keefe EA, Ackerman S, Watermeyer S, Louw J, Adams G, Girdwood AH, Burns DG, Marks IN. The epidemiology of inflammatory bowel disease in Cape Town 1980-1984. S Afr Med J. 1986 Jul 5;70(1):10-5.</citation>
    <PMID>3726680</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Brian Bressler</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02193750
org study id: H14-01420
nct id: NCT02193750
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The investigators hypothesize that a novel method for oligosaccharide supplementation, in the
      form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS),
      will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD)
      in remission.
Subjects age >/= 19 years with the diagnosis of CD for >/= 6 months, currently in remission
      based on the Harvey-Bradshaw Index score (</=4 points) and C-reactive protein (<5 mg/L) will
      be recruited from two academic hospitals and affiliated gastroenterology outpatient clinics
      (St. Paul's Hospital, Vancouver, British Columbia, Canada; Alfred Hospital, Melbourne,
      Victoria, Australia).

      The study is a randomized, double-blind, placebo-controlled trial that consist of a 2-week
      run-in period followed by a 4-week study period. Prior to study entry, a screening visit will
      be required for all potential participants. If a participant meets the inclusion criteria,
      they will be randomized to either a placebo (0.55 g total fructans/GOS), a moderate
      oligosaccharide group (3.25 g total fructans/GOS) or a high oligosaccharide group (5.43 g
      total fructans/GOS) through a computed-generated scheme within each respective center. During
      the run-in period, enrolled subjects will undergo the following: 1) Laboratory analyses (CBC,
      routine biochemistry, CRP and fecal calprotectin); 2) Stool collection for fecal calprotectin
      analysis; 3) tolerability assessment including overall gastrointestinal symptoms and specific
      symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) utilizing a 100mm
      visual analogue scale (VAS, 0 = no symptoms; 100 = worst symptoms ever experienced); 4)
      fatigue assessment utilizing a multi-dimensional fatigue impact scale (FIS); 5)
      health-related quality of life (HRQOL) assessment utilizing the Short Form 36-Item Health
      Survey (SF-36) and 6) Mood assessment utilizing the Spielberger State-Trait Personality
      Inventory (STPI). Participants will also meet with a registered dietitian to quantify
      baseline oligosaccharide consumption by completing a prospective 5-day diet diary alongside a
      validated food frequency questionnaire (FFQ), the Monash University Comprehensive Nutritional
      Assessment Questionnaire (CNAQ) that assesses oligosaccharide intake in addition to the usual
      nutrients [49]. Once the initial dietary assessment is complete, participants will begin
      up-titration of their oligosaccharide supplementation in a step-wise fashion until they reach
      their required daily amounts defined by their treatment group allocation. Once this is
      achieved, they will enter the 4 weeks of treatment or at time of relapse. Participants will
      undergo re-assessment during the study period at 2 weeks (Visit #3), and at study completion
      (Visit #4).

      If a participant undergoes a CD flare during the run-in period, they will be withdrawn from
      the study. The end point of the study will be at 4 weeks of treatment or at time of relapse.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Difference in overall GI symptoms
time frame: 5 days
description: The primary outcome will be the difference in overall gastrointestinal symptoms quantified by the VAS, at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups.
measure: Tolerability assessment including overall gastrointestinal symptoms and specific symptoms
time frame: 4 weeks
description: Secondary outcomes concerning tolerability will include differences in the individual gastrointestinal symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) quantified by the VAS at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups.
measure: Fatigue assessment
time frame: 4 weeks
description: Secondary endpoints concerning differences in the scores of the overall FIS (fatigue impact scale) and sub-categories (physical, cognitive, psychosocial) at study completion compared to baseline in all 3 study groups
measure: Quality of Life Assessment
time frame: 4 weeks
description: Secondary endpoints concerning differences in physical components summary (PCS) and the mental component summary (MSC) scores at study completion compared to baseline in all 3 study groups respectively
measure: Mood Assessment
time frame: 4 weeks
description: Secondary endpoints concerning mood that will include differences in state anxiety, state curiosity, state anger, and state depression scores of the STPI at study completion compared to baseline in all 3 study groups respectively
measure: Disease Activity Asessment
time frame: 4 weeks
description: The proportion of participants who relapse, as well as the time to relapse at study completion between groups.
measure: Adherence Assessment
time frame: 4 weeks
description: Adherence will be estimated and compared between groups at study completion
arm group label: Placebo
arm group type: Placebo Comparator
description: 1 placebo muesli bars and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
arm group label: Moderate Oligosaccharide Group
arm group type: Experimental
description: 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
arm group label: High Oligosaccharide Group
arm group type: Experimental
description: 1 intervention muesli bar and 1 serving intervention muesli per day (5.43 total fructans/GOS)
intervention type: Dietary Supplement
intervention name: Placebo
description: 1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Moderate Oligosaccharide Group
description: 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
arm group label: Moderate Oligosaccharide Group
intervention type: Dietary Supplement
intervention name: High Oligosaccharide Group
description: 1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)
arm group label: High Oligosaccharide Group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Bressler, MD
role: Principal Investigator
affiliation: Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda
last name: Peter Gibson, MD
role: Principal Investigator
affiliation: Department of Gastroenterology Alfred Hospital, Melbourne, Australia
facility: 
facility: 
country: Australia
country: Canada
citation: Talley NJ, Abreu MT, Achkar JP, Bernstein CN, Dubinsky MC, Hanauer SB, Kane SV, Sandborn WJ, Ullman TA, Moayyedi P; American College of Gastroenterology IBD Task Force. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011 Apr;106 Suppl 1:S2-25; quiz S26. doi: 10.1038/ajg.2011.58. No abstract available.
PMID: 21472012
citation: Kappelman MD, Rifas-Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, Finkelstein JA. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1424-9. doi: 10.1016/j.cgh.2007.07.012. Epub 2007 Sep 29.
PMID: 17904915
citation: Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x.
PMID: 18796097
citation: Lichtenstein GR, Hanauer SB, Sandborn WJ; Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009 Feb;104(2):465-83; quiz 464, 484. doi: 10.1038/ajg.2008.168. Epub 2009 Jan 6.
PMID: 19174807
citation: Pai CG, Khandige GK. Is Crohn's disease rare in India? Indian J Gastroenterol. 2000 Jan-Mar;19(1):17-20.
PMID: 10659482
citation: El Mouzan MI, Abdullah AM, Al Habbal MT. Epidemiology of juvenile-onset inflammatory bowel disease in central Saudi Arabia. J Trop Pediatr. 2006 Feb;52(1):69-71. doi: 10.1093/tropej/fmi039. Epub 2005 Jun 9.
PMID: 15947013
citation: Ouyang Q, Tandon R, Goh KL, Ooi CJ, Ogata H, Fiocchi C. The emergence of inflammatory bowel disease in the Asian Pacific region. Curr Opin Gastroenterol. 2005 Jul;21(4):408-13.
PMID: 15930979
citation: Aghazadeh R, Zali MR, Bahari A, Amin K, Ghahghaie F, Firouzi F. Inflammatory bowel disease in Iran: a review of 457 cases. J Gastroenterol Hepatol. 2005 Nov;20(11):1691-5. doi: 10.1111/j.1440-1746.2005.03905.x.
PMID: 16246187
citation: Wright JP, Froggatt J, O'Keefe EA, Ackerman S, Watermeyer S, Louw J, Adams G, Girdwood AH, Burns DG, Marks IN. The epidemiology of inflammatory bowel disease in Cape Town 1980-1984. S Afr Med J. 1986 Jul 5;70(1):10-5.
PMID: 3726680
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Brian Bressler
investigator title: Clinical Associate Professor
mesh term: Crohn Disease