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Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Mount Sinai Hospital
Toronto, Ontario, Canada
Start Date
March 1, 2021
Primary Completion Date
September 30, 2026
Completion Date
September 30, 2026
Last Updated
September 29, 2025
20
ESTIMATED participants
UC intervention diet
OTHER
Lead Sponsor
Mount Sinai Hospital, Canada
Collaborators
NCT05076175
NCT06651281
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06065228