Diet Intervention Treatment for Active Ulcerative Colitis

Recruiting now · Not applicable

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT04121806

Run by

Mount Sinai Hospital, Canada

People needed

20

Starts

2021-03-01

Expected to finish

2026-09-30

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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.

Where it is running

• Mount Sinai Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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