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NCT04121806Recruiting

Diet Intervention Treatment for Active Ulcerative Colitis

Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
30 Sept 2019
Start date
1 Mar 2021
Primary completion date
30 Sept 2026
Lead sponsor
Mount Sinai Hospital, Canada
NCT number
NCT04121806

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 Mar 2021 to the primary completion date, 30 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • • 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.

Who the study is looking for

  • • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Mount Sinai Hospital
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.