Actively Recruiting
Diet Intervention Treatment for Active Ulcerative Colitis
Led by Mount Sinai Hospital, Canada · Updated on 2025-09-29
20
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
Sponsors
M
Mount Sinai Hospital, Canada
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diet Intervention Treatment for Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females and males between 18 and 75 years old at enrollment
- Established diagnosis of ulcerative colitis by standard endoscopic, radiographic, or histological criteria
- Active ulcerative colitis with Mayo score of 2 or greater within two months prior to enrollment
- History of ulcerative colitis affecting more than 10 cm of the colon
- Fecal calprotectin (FCP) greater than 250 or active endoscopy within 6 months
- If a smoker, no change in smoking habits during the study
- Stable medical therapy with no changes 4 weeks before and during the study
You will not qualify if you...
- Uncontrolled inflammation likely requiring surgery or therapy escalation within 4 weeks of enrollment
- Pregnant or lactating females
- Allergy or intolerance to major components of the study diet
- Current use of NSAIDs
- Diagnosed with primary sclerosing cholangitis (PSC)
- Using topical therapies or suppositories
- Antibiotic use within 4 weeks before or during the study
- Confirmed Clostridium difficile infection within 3 months before recruitment
- History of dysplasia or colorectal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
Research Team
J
Jenny Lee
CONTACT
J
Joanne Stempak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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