Microbiota-targeted Diet for Pediatric UC

Study Overview
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Brief Summary
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Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.

Official Title
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Use of a Novel Diet (UC Diet) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Ulcerative Colitis Diet (UCD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Established diagnosis of UC Age: 8-19 (inclusive) Mild to moderate active disease, 10<PUCAI<45 Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks. Participant has agreed to follow the UCD for 12 weeks Exclusion Criteria: Any proven current infection such as positive stool culture, parasite or C. difficile within the past 4 weeks Antibiotic or corticosteroid use in the past 2 weeks Use of biologics in present or in the past PUCAI>45 Acute severe UC in the previous 12 months Current extra intestinal manifestation of UC Primary Sclerosing Cholangitis (PSC) or liver disease Pregnancy Known food allergy to mandatory foods in the UCD

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulcerative Colitis Diet<br>Participants will receive a structured 12-week diet with a step down phase. | Other: Ulcerative Colitis Diet (UCD)<br>* The primary study intervention is a novel dietary intervention, the UC Diet. The UC Diet is a structured 12-week diet with a step down phase designed to remove products that allow harmful bacteria to thrive and add products that can change the bacteria in the gut to induce remission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission | Remission defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) | At 6 weeks following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Compliance | Using modified Medication Adherence Rating Scale (MARS) questionnaire | Up to 12 weeks following enrollment | 
| Change in C-reactive protein (CRP) between baseline and week 12 |  | 12 weeks | 
| Change in erythrocyte sedimentation rate (ESR) between baseline and week 12 |  | 12 weeks | 
| Change in fecal calprotectin (FCP) between baseline and week 12 |  | 12 weeks | 
| Microbial composition of the gastrointestinal tract | Change in the microbial composition of the stool and rectum from baseline to 12 weeks. | 12 weeks |