Diet Intervention Treatment for Active Ulcerative Colitis
Not applicable · Testing UC intervention diet · 1 site · Mount Sinai Hospital, Canada
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing UC intervention diet as a possible treatment. Condition(s) listed: Colitis, Ulcerative.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- • 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
Plus 4 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2021-03-01.
- Main results expected around 2026-09-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Change in microbiome composition (10 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative |
| Lead sponsor | Mount Sinai Hospital, Canada |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 20 (estimated) |
| Start date | 2021-03-01 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2019-10-10 |
| Last updated | 2025-09-29 |
| Official title | Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT04121806 |
Interventions
- UC intervention diet (Other)
The treatment diet has been designed based on the literature with the goal of influencing the biodiversity and density of the microbiome. All food through the duration of the 8 week dietary intervention period of the study will be provided to the treatment arm study participants.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital | Toronto, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.