Diet Intervention Treatment for Active Ulcerative Colitis

Official title

Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis

Overview

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

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.

Interventions

• Other UC intervention diet
  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.

Primary outcome measures

• Change in microbiome composition [Time frame: 10 weeks]
• Change in microbiome function [Time frame: 10 weeks]

Secondary outcome measures (2)

• Decrease in endoscopic disease activity [Time frame: 10 weeks]
• Decrease in clinical disease activity [Time frame: 10 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Mount Sinai Hospital — Toronto

Identifiers

NCT: NCT04121806 · 19-0112-A · 3U01DK062423-18S1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗