Diet Intervention Treatment for Active Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.

Detailed Description
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The etiology of inflammatory bowel disease (IBD), including ulcerative colitis (UC), is complex and poorly understood, but the current hypothesis is that IBD arises from an aberrant immune response to commensal bacteria in a genetically susceptible host, and is triggered by environmental factors. Environmental factors such as the microbiome and diet, play a significant role in the risk of IBD. Diet has been identified as one of the main drivers of the microbiome composition and the microbiome and diet can work in tandem to affect host physiology. In spite of patient interest in diet and numerous diet studies, currently there is no diet that is clinically validated or universally agreed upon for adult IBD patients. We also lack rigorous studies to show how the microbiome is influenced by diet and affects patient outcomes. We propose to use a sustainable non-elemental diet aimed at altering the microbiome in patients with mild to moderately active UC to alter their disease activity.

Official Title
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Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Other: UC intervention diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Females and Males between the ages of 18 - 75 years of age at the time of enrolment Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment Must have had > 10cm involvement at some point in their disease history FCP>250 or active endo within 6 months If a smoker, must not change smoking habits (frequency) during the course of the study If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study Exclusion Criteria: • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment Pregnant or lactating females Allergy or intolerance to key or a great number food components of the study diet Current NSAID use Diagnosed with PSC Using topical therapies or suppositories Antibiotic use within 4 weeks of the study enrollment or during the study Confirmed C. difficile infection within 3 months of recruitment; Diagnosis of primary PSC; Currently using topical therapies or suppositories History of dysplasia or colorectal neoplasia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 patients with mild to moderate activity<br>Participants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet. | Other: UC intervention diet<br>* The treatment diet has been designed based on the literature with the goal of influencing the biodiversity and density of the microbiome. All food through the duration of the 8 week dietary intervention period of the study will be provided to the treatment arm study participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiome composition | measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual | 10 weeks | 
| Change in microbiome function | measured by shotgun sequencing and comparing difference in enriched functional pathways between pretreatment diet and the treatment diet within an individual | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in endoscopic disease activity | measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual | 10 weeks | 
| Decrease in clinical disease activity | measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual | 10 weeks |