Diet Intervention Treatment for Active Ulcerative Colitis
Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
September 29, 2025
September 1, 2025
5.6 years
September 30, 2019
September 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in microbiome composition
measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual
10 weeks
Change in microbiome function
measured by shotgun sequencing and comparing difference in enriched functional pathways between pretreatment diet and the treatment diet within an individual
10 weeks
Secondary Outcomes (2)
Decrease in endoscopic disease activity
10 weeks
Decrease in clinical disease activity
10 weeks
Study Arms (1)
Ulcerative colitis patients with mild to moderate activity
EXPERIMENTALParticipants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 10, 2019
Study Start
March 1, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Study results or individual subject results such as investigational tests will not be shared with the research participants or others unless deemed medically necessary. Result of this research and management of intellectual property will adherence to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources issued March 5, 2003. Publication of data during the project and/or at the end of the project shall be consistent with normal scientific practices. Research data which documents, supports, and validates research findings will be made available after the main findings from the final research data set have been accepted for publication.