<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/NCT03301311</url>
  </required_header>
  <id_info>
    <org_study_id>CIN001-PRODUCE</org_study_id>
    <nct_id>NCT03301311</nct_id>
  </id_info>
  <brief_title>Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease</brief_title>
  <acronym>PRODUCE</acronym>
  <official_title>Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions--Aim 1: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dayton Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A series of N-of-1 trials will be used to determine the effectiveness of a specific&#xD;
      carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and&#xD;
      inflammatory burden at both the individual and population level. This is a four-year study.&#xD;
      The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18&#xD;
      with mild to moderate disease activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Actual">September 8, 2020</completion_date>
  <primary_completion_date type="Actual">September 8, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>We are using a series of N-of-1 trials where patients alternate (cross) between the two study interventions at set intervals. N-of-1 trial results will be examined at the individual and population level (through meta-analysis of individual N-of-1 trials)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stool frequency</measure>
    <time_frame>Daily through study completion (34 weeks from randomization)</time_frame>
    <description>Self-reported number of stools per day entered as an integer in the study mobile app</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stool Consistency</measure>
    <time_frame>Daily through study completion (34 weeks from randomization)</time_frame>
    <description>Self-reported assessment of stool consistency using the Bristol Stool Scale entered in the study mobile app</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>Weekly through study completion (34 weeks from randomization)</time_frame>
    <description>Patient reported outcome of pain interference measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale on the study app. The scale includes 8 items and responses to each item are on a 0 (Never) to 4 (Almost Always) scale. Higher scores indicate greater pain interference. Look up tables provided by the PROMIS Assessment Center will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal Symptoms</measure>
    <time_frame>Weekly through study completion (34 weeks from randomization)</time_frame>
    <description>Self-reported outcome of GI symptom burden measured using the PROMIS GI Symptoms scale on the study app. The scale includes 4 items and responses to each item are on a 1 (Never) to 5 (Almost Always) scale. Higher scores indicate greater GI symptom burden. Look up tables provided by the measure developers will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal Calprotectin</measure>
    <time_frame>At baseline and once at the end of each treatment period (weeks 10, 18, 26 and 34) for a total of 5 times</time_frame>
    <description>Laboratory measurement of intestinal inflammation. Stool will be collected by participants at home and will be mailed to a central lab for processing and analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider measured disease activity</measure>
    <time_frame>At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)</time_frame>
    <description>Pediatric Ulcerative Colitis Index (PUCAI) or Short Pediatric Crohn's Index (sPCDAI) are completed by care providers at all scheduled clinic visits as part of standard of care and are entered into the ImproveCareNow (ICN) registry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory markers of disease activity and inflammation</measure>
    <time_frame>At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)</time_frame>
    <description>C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), albumin, and hematocrit as collected as part of standard of care and are entered into the ImproveCareNow (ICN) registry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>At baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)</time_frame>
    <description>Weight and height are collected at all clinic visits and at the dietitian study follow up visits (2 weeks into the first diet period of each diet). These data are entered into the ICN registry as part of regular data entry. We will calculate weight for age Z-scores for all entries during study period. The age-specific mean and standard deviation from U.S. population norms will be used to calculate Z-scores using the Centers for Disease Control Epi-Info program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Crohn's Disease Activity Index (sCDAI)</measure>
    <time_frame>Weekly through study completion (34 weeks from randomization)</time_frame>
    <description>The short Crohn's disease activity index (sCDAI) will be used to assess disease activity based on self-report via the study app. For the sCDAI, items assess general well-being, abdominal pain, and liquid stools. Respondents are asked to report on symptoms for the previous 24 hour period. Scores are calculated based on a published algorithm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Ulcerative Colitis Activity Index (PUCAI)</measure>
    <time_frame>Weekly through study completion (34 weeks from randomization)</time_frame>
    <description>A self-reported version of the Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to assess disease activity based on self-report via the study app. For the PUCAI, respondents are asked to report on abdominal pain, bloody stools, stool consistency, stool frequency, nocturnal stools, and activity level over the prior 24-hours. A weighted, summed score is calculated with higher scores indicating worse disease (score range 0-85).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Crohn Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Indeterminate Colitis</condition>
  <arm_group>
    <arm_group_label>Specific Carbohydrate Diet (First)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Specific Carbohydrate Diet (First)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Specific Carbohydrate Diet (SCD)</intervention_name>
    <description>Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.</description>
    <arm_group_label>Modified Specific Carbohydrate Diet (First)</arm_group_label>
    <arm_group_label>Specific Carbohydrate Diet (First)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modified Specific Carbohydrate Diet (MSCD)</intervention_name>
    <description>Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.</description>
    <arm_group_label>Modified Specific Carbohydrate Diet (First)</arm_group_label>
    <arm_group_label>Specific Carbohydrate Diet (First)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis&#xD;
             (IC)&#xD;
&#xD;
          -  Age 7-18 years&#xD;
&#xD;
          -  Enrolled in the ImproveCareNow (ICN2) registry&#xD;
&#xD;
          -  Evidence of acute inflammation and/or elevated acute phase reactant as measured by&#xD;
             Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the&#xD;
             upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the&#xD;
             upper limit of normal (based on local reference ranges) obtained within 8 weeks of&#xD;
             enrollment.&#xD;
&#xD;
               -  Potential participants who are close to meeting one of the acute inflammation&#xD;
                  and/or elevated acute phase reactant markers and who meet all other study&#xD;
                  criteria will be considered for study participation on a case by case basis by&#xD;
                  the investigative study team in consultation with the patient's primary&#xD;
                  gastroenterologist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Complex and Unstable IBD:&#xD;
&#xD;
          -  Currently or within the past 9 months has had an abscess, fistula, stricturing CD, or&#xD;
             ostomy&#xD;
&#xD;
          -  Severe disease activity as measured by a short Pediatric Crohn's Disease Activity&#xD;
             Index (SPCDAI) score of &gt;45 or Pediatric Ulcerative Colitis Activity Index (PUCAI)&#xD;
             score of &gt;60 assessed within three weeks of enrollment&#xD;
&#xD;
          -  Ever had history of full colectomy&#xD;
&#xD;
          -  Hospitalization or surgery planned within 3 months&#xD;
&#xD;
          -  Ongoing active gastrointestinal infection&#xD;
&#xD;
          -  Severe Malnutrition (BMI less than 5th percentile)&#xD;
&#xD;
          -  Recent medication changes including:&#xD;
&#xD;
               -  Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to&#xD;
                  enrollment&#xD;
&#xD;
               -  Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment&#xD;
&#xD;
               -  Vedolizumab started within 16 weeks prior to enrollment&#xD;
&#xD;
               -  Increase in corticosteroids within 4 weeks of screening or have dose &gt;20 mg&#xD;
                  prednisone or equivalent&#xD;
&#xD;
        Evidence of Other Complicating Medical Issues:&#xD;
&#xD;
          -  Other serious medical conditions, such as neurological, liver, kidney, or systemic&#xD;
             disease&#xD;
&#xD;
          -  Serious psychological or psychiatric conditions such as eating disorders or self-harm&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Tobacco, alcohol, or illicit drug abuse&#xD;
&#xD;
        Inability to Complete the Protocol&#xD;
&#xD;
          -  Non-English speaking participants&#xD;
&#xD;
          -  On SCD or modified SCD anytime within 8 weeks of enrollment&#xD;
&#xD;
               -  If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of&#xD;
                  enrollment but they are noncompliant per the determination of the patient's&#xD;
                  dietitian/primary gastroenterologist, then this patient is eligible to&#xD;
                  participant in the study.&#xD;
&#xD;
          -  Participants on a vegan diet&#xD;
&#xD;
          -  Lack of smart phone and data plan for participating caregiver&#xD;
&#xD;
          -  Participating in another concurrent intervention study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather C Kaplan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Opipari-Arrigan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Benioff Children's Hospital Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco Benioff Children's Hospita;</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours, Alfred I duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Speciality Care</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Care for Kids</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Children's Hospital</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health Sciences University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dell Children's Medical Center of Central Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Soutwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Specialists of Virginia</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of the King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kaplan HC, Opipari-Arrigan L, Yang J, Schmid CH, Schuler CL, Saeed SA, Braly KL, Chang F, Murphy L, Dodds CM, Nuding M, Liu H, Pilley S, Stone J, Woodward G, Yokois N, Goyal A, Lee D, Yeh AM, Lee P, Gold BD, Molle-Rios Z, Zwiener RJ, Ali S, Chavannes M, Linville T, Patel A, Ayers T, Bassett M, Boyle B, Palomo P, Verstraete S, Dorsey J, Kaplan JL, Steiner SJ, Nguyen K, Burgis J, Suskind DL; ImproveCareNow Pediatric IBD Learning Health System. Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials. Am J Gastroenterol. 2022 Jun 1;117(6):902-917. doi: 10.14309/ajg.0000000000001800. Epub 2022 Apr 20.</citation>
    <PMID>35442220</PMID>
  </results_reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>June 22, 2022</last_update_submitted>
  <last_update_submitted_qc>June 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2022</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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We intend to provide access to the de-identified, HIPAA-compliant databases as required within a year after the study has been completed. Data plans, analysis plans, data dictionaries, study manuals and annotated case report forms will be made available, upon request, in a read-only format (PDF). Each dataset will be accompanied by appropriate documentation listing each variable, variable definition, decode values (if appropriate), an indication of the variable as a source collected or derived variable, and derivation algorithms for any derived values.&#xD;
Datasets will be available as SAS, SAS transport, XML or CSV with labels. Other formats may be created if requested. All necessary security measures will be taken to ensure patient privacy and confidentiality, and details on how data may be used, including the use of de-identified data sets, will be included in the informed consent.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Within a year after study completion.</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03301311/Prot_SAP_006.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03301311
org study id: CIN001-PRODUCE
nct id: NCT03301311
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A series of N-of-1 trials will be used to determine the effectiveness of a specific
      carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and
      inflammatory burden at both the individual and population level. This is a four-year study.
      The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18
      with mild to moderate disease activity.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: We are using a series of N-of-1 trials where patients alternate (cross) between the two study interventions at set intervals. N-of-1 trial results will be examined at the individual and population level (through meta-analysis of individual N-of-1 trials)
primary purpose: Treatment
masking: None (Open Label)
measure: Stool frequency
time frame: Daily through study completion (34 weeks from randomization)
description: Self-reported number of stools per day entered as an integer in the study mobile app
measure: Stool Consistency
time frame: Daily through study completion (34 weeks from randomization)
description: Self-reported assessment of stool consistency using the Bristol Stool Scale entered in the study mobile app
measure: Pain Interference
time frame: Weekly through study completion (34 weeks from randomization)
description: Patient reported outcome of pain interference measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale on the study app. The scale includes 8 items and responses to each item are on a 0 (Never) to 4 (Almost Always) scale. Higher scores indicate greater pain interference. Look up tables provided by the PROMIS Assessment Center will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
measure: Gastrointestinal Symptoms
time frame: Weekly through study completion (34 weeks from randomization)
description: Self-reported outcome of GI symptom burden measured using the PROMIS GI Symptoms scale on the study app. The scale includes 4 items and responses to each item are on a 1 (Never) to 5 (Almost Always) scale. Higher scores indicate greater GI symptom burden. Look up tables provided by the measure developers will be used to transform the raw score to a T-score such that 50 is the mean for the population with a standard deviation of 10.
measure: Fecal Calprotectin
time frame: At baseline and once at the end of each treatment period (weeks 10, 18, 26 and 34) for a total of 5 times
description: Laboratory measurement of intestinal inflammation. Stool will be collected by participants at home and will be mailed to a central lab for processing and analysis.
measure: Provider measured disease activity
time frame: At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
description: Pediatric Ulcerative Colitis Index (PUCAI) or Short Pediatric Crohn's Index (sPCDAI) are completed by care providers at all scheduled clinic visits as part of standard of care and are entered into the ImproveCareNow (ICN) registry.
measure: Laboratory markers of disease activity and inflammation
time frame: At baseline, 10 weeks and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
description: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), albumin, and hematocrit as collected as part of standard of care and are entered into the ImproveCareNow (ICN) registry.
measure: Growth
time frame: At baseline, week 4, week 10, week 12 and up to 2 -4 more times as standard of care visits for the duration of the study (34 weeks from randomization)
description: Weight and height are collected at all clinic visits and at the dietitian study follow up visits (2 weeks into the first diet period of each diet). These data are entered into the ICN registry as part of regular data entry. We will calculate weight for age Z-scores for all entries during study period. The age-specific mean and standard deviation from U.S. population norms will be used to calculate Z-scores using the Centers for Disease Control Epi-Info program.
measure: Short Crohn's Disease Activity Index (sCDAI)
time frame: Weekly through study completion (34 weeks from randomization)
description: The short Crohn's disease activity index (sCDAI) will be used to assess disease activity based on self-report via the study app. For the sCDAI, items assess general well-being, abdominal pain, and liquid stools. Respondents are asked to report on symptoms for the previous 24 hour period. Scores are calculated based on a published algorithm.
measure: Pediatric Ulcerative Colitis Activity Index (PUCAI)
time frame: Weekly through study completion (34 weeks from randomization)
description: A self-reported version of the Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to assess disease activity based on self-report via the study app. For the PUCAI, respondents are asked to report on abdominal pain, bloody stools, stool consistency, stool frequency, nocturnal stools, and activity level over the prior 24-hours. A weighted, summed score is calculated with higher scores indicating worse disease (score range 0-85).
arm group label: Specific Carbohydrate Diet (First)
arm group type: Experimental
description: Participants will be following the Specific Carbohydrate Diet (SCD). Allowed foods include meat/fish/poultry, eggs, some legumes (e.g., lentils and split peas are permitted, chickpeas and soybeans are not), fully fermented yogurt, non-starchy vegetables, ripe fruit, nuts/seeds, honey and nut flours (e.g. almond flour or coconut flour). Restricted foods include all grains, milk products aside from 24-hour fermented SCD yogurt and cheeses aged greater than 30 days, starchy vegetables, processed foods with food additives and sweeteners other than honey.
arm group label: Modified Specific Carbohydrate Diet (First)
arm group type: Experimental
description: Participants will be following a modified Specific Carbohydrate Diet (MSCD). In addition to the foods in the SCD, allowed foods will expand to include organic rice, oats, sweet potatoes, grade A maple syrup and cocoa. Gluten, corn products, milk products (except yogurt and hard cheeses), sweeteners (except honey), and process foods are still restricted.
intervention type: Other
intervention name: Specific Carbohydrate Diet (SCD)
description: Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
arm group label: Modified Specific Carbohydrate Diet (First)
arm group label: Specific Carbohydrate Diet (First)
intervention type: Other
intervention name: Modified Specific Carbohydrate Diet (MSCD)
description: Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
arm group label: Modified Specific Carbohydrate Diet (First)
arm group label: Specific Carbohydrate Diet (First)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
last name: Heather C Kaplan, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
last name: Lisa Opipari-Arrigan, PhD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Kaplan HC, Opipari-Arrigan L, Yang J, Schmid CH, Schuler CL, Saeed SA, Braly KL, Chang F, Murphy L, Dodds CM, Nuding M, Liu H, Pilley S, Stone J, Woodward G, Yokois N, Goyal A, Lee D, Yeh AM, Lee P, Gold BD, Molle-Rios Z, Zwiener RJ, Ali S, Chavannes M, Linville T, Patel A, Ayers T, Bassett M, Boyle B, Palomo P, Verstraete S, Dorsey J, Kaplan JL, Steiner SJ, Nguyen K, Burgis J, Suskind DL; ImproveCareNow Pediatric IBD Learning Health System. Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials. Am J Gastroenterol. 2022 Jun 1;117(6):902-917. doi: 10.14309/ajg.0000000000001800. Epub 2022 Apr 20.
PMID: 35442220
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Inflammatory Bowel Diseases
mesh term: Ulcer
sharing ipd: Yes
ipd description: We intend to provide access to the de-identified, HIPAA-compliant databases as required within a year after the study has been completed. Data plans, analysis plans, data dictionaries, study manuals and annotated case report forms will be made available, upon request, in a read-only format (PDF). Each dataset will be accompanied by appropriate documentation listing each variable, variable definition, decode values (if appropriate), an indication of the variable as a source collected or derived variable, and derivation algorithms for any derived values.
Datasets will be available as SAS, SAS transport, XML or CSV with labels. Other formats may be created if requested. All necessary security measures will be taken to ensure patient privacy and confidentiality, and details on how data may be used, including the use of de-identified data sets, will be included in the informed consent.
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Within a year after study completion.
provided document: 