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Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease (PRODUCE)

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ClinicalTrials.gov Identifier: NCT03301311
Recruitment Status : Active, not recruiting
First Posted : October 4, 2017
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
University of California, San Francisco
Seattle Children's Hospital
Dayton Children's Hospital
Brown University
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Indeterminate Colitis Other: Specific Carbohydrate Diet (SCD) Other: Modified Specific Carbohydrate Diet (MSCD) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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)
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : December 2, 2020
Estimated Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Specific Carbohydrate Diet (First)
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.
 Other: Specific Carbohydrate Diet (SCD)
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.

Other: Modified Specific Carbohydrate Diet (MSCD)
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.
Experimental: Modified Specific Carbohydrate Diet (First)
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.
 Other: Specific Carbohydrate Diet (SCD)
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.

Other: Modified Specific Carbohydrate Diet (MSCD)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Stool frequency [ Time Frame: Daily through study completion (34 weeks from randomization) ]
    Self-reported number of stools per day entered as an integer in the study mobile app

  2. Stool Consistency [ Time Frame: Daily through study completion (34 weeks from randomization) ]
    Self-reported assessment of stool consistency using the Bristol Stool Scale entered in the study mobile app

  3. Pain Interference [ Time Frame: Weekly through study completion (34 weeks from randomization) ]
    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.

  4. Gastrointestinal Symptoms [ Time Frame: Weekly through study completion (34 weeks from randomization) ]
    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.

  5. 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 ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    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.

  4. Short Crohn's Disease Activity Index (sCDAI) [ Time Frame: Weekly through study completion (34 weeks from randomization) ]
    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.

  5. Pediatric Ulcerative Colitis Activity Index (PUCAI) [ Time Frame: Weekly through study completion (34 weeks from randomization) ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis (IC)
  • Age 7-18 years
  • Enrolled in the ImproveCareNow (ICN2) registry

  • Evidence of acute inflammation and/or elevated acute phase reactant as measured by Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment.

    • Potential participants who are close to meeting one of the acute inflammation and/or elevated acute phase reactant markers and who meet all other study criteria will be considered for study participation on a case by case basis by the investigative study team in consultation with the patient's primary gastroenterologist.

Exclusion Criteria:

Complex and Unstable IBD:

  • Currently or within the past 9 months has had an abscess, fistula, stricturing CD, or ostomy
  • Severe disease activity as measured by a short Pediatric Crohn's Disease Activity Index (SPCDAI) score of >45 or Pediatric Ulcerative Colitis Activity Index (PUCAI) score of >60 assessed within three weeks of enrollment
  • Ever had history of full colectomy
  • Hospitalization or surgery planned within 3 months
  • Ongoing active gastrointestinal infection
  • Severe Malnutrition (BMI less than 5th percentile)

  • Recent medication changes including:

    • Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to enrollment
    • Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment
    • Vedolizumab started within 16 weeks prior to enrollment
    • Increase in corticosteroids within 4 weeks of screening or have dose >20 mg prednisone or equivalent

Evidence of Other Complicating Medical Issues:

  • Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
  • Serious psychological or psychiatric conditions such as eating disorders or self-harm
  • Pregnancy
  • Tobacco, alcohol, or illicit drug abuse

Inability to Complete the Protocol

  • Non-English speaking participants

  • On SCD or modified SCD anytime within 8 weeks of enrollment

    • If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of enrollment but they are noncompliant per the determination of the patient's dietitian/primary gastroenterologist, then this patient is eligible to participant in the study.
  • Participants on a vegan diet
  • Lack of smart phone and data plan for participating caregiver
  • Participating in another concurrent intervention study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301311


Locations
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Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
University of California, San Francisco
Seattle Children's Hospital
Dayton Children's Hospital
Brown University
Investigators
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Principal Investigator: Heather C Kaplan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Lisa Opipari-Arrigan, PhD Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Study Protocol and Statistical Analysis Plan  [PDF] January 31, 2020

More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03301311    
Other Study ID Numbers: CIN001-PRODUCE
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Within a year after study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes