Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

Study Overview
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Brief Summary
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This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.

Official Title
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The Fibre Study: RCT of Personalized Fibre Diet in IBD

Conditions
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Inflammatory Bowel Diseases, Ulcerative Colitis

Intervention / Treatment
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* Other: Placebo Comparator: Randomized pectin diet
* Other: Randomized B-fructan diet
* Other: Personalized pectin diet
* Other: Personalized B-fructan diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (age 6-17) or young adults (age 18-39). Known or suspected UC or IBDU [there will be 2 control group: non-IBD (undergoing colonoscopy but found not to have IBD; and healthy (no GI symptoms, so not required to have colonoscopy; could be family members)] For UC: Remission-mild-moderate disease: Mayo score <10 Clinical indication for sedated colonoscopy Disease location: E2-E4 Stable treatment (not on steroids; biologics or immunomodulator not changed in last month) High likelihood that patients will be able to collect all samples and provide all data Exclusion Criteria: Use of antibiotics for a week or more over the last 3 months Use of probiotics or prebiotics at pharmacological doses (adding fibre sources to food or probiotics in yogurt, for example, are allowed) History of abdominal surgery, including appendectomy Documented enteric infection during the 3 months prior to endoscopy Presence of non-IBD bowel conditions (e.g., celiac), anatomical or mucosal abnormalities, motility disorder Presence of a systemic disease requiring treatment (cancer, ischemic heart disease, kidney failure, etc) Proctitis (E1) Systemic steroids (above 10 mg/day of Prednisone) Topical therapy within 1 week of endoscopy Recent change in IBD treatment (started biologics or IM over the last month) Pregnancy or planning to become pregnant during the study Inability to understand or sign the consent

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Randomized pectin diet<br> | Other: Placebo Comparator: Randomized pectin diet<br>* UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin<br>|
| Placebo Comparator: Randomized B-fructan diet<br> | Other: Randomized B-fructan diet<br>* UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan<br>|
| Experimental: Personalized pectin diet<br> | Other: Personalized pectin diet<br>* UC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in pectin based on personal host (biopsy) and microbe (stool) response at baseline<br>|
| Experimental: Personalized B-fructan diet<br> | Other: Personalized B-fructan diet<br>* UC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan based on personal host (biopsy) and microbe (stool) response at baseline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet tolerability | Percentage of patients able to tolerate a personalized fiber diet provided by a dietitian will be evaluated at week 4 by measure of patient symptom score (PROMIS questionnaire) and willingness to continue adherence to diet advice provided. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response to diet | Host inflammatory response to personalized dietary fibre recommendations provided by dietitian will be determined by examining changes in markers of inflammation in blood and stool | 1 week, 4 weeks, 8 weeks, 12 weeks | 
| Microbiota changes in response to diet | Host microbiota response to personalized dietary fibre recommendations provided by dietitian will be determined by examining changes in microbe abundance, diversity and functions by shotgun metagenomics in stool | 1 week, 4 weeks, 8 weeks, 12 weeks |