NCT04121806 Diet Intervention Treatment for Active Ulcerative Colitis
| NCT ID | NCT04121806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Colitis, Ulcerative |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2021-03-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 decrease disease activity.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04121806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colitis, Ulcerative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04121806 currently recruiting?
Yes, NCT04121806 is actively recruiting participants. Contact the research team at jenny.lee@sinaihealth.ca for enrollment information.
Where is the NCT04121806 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04121806 clinical trial?
NCT04121806 is sponsored by Mount Sinai Hospital, Canada. The trial plans to enroll 20 participants.