Status:
RECRUITING
Diet Intervention Treatment for Active Ulcerative Colitis
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04121806
Start Date
March 1 2021
End Date
September 30 2026
Last Update
September 29 2025
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5