Diet Intervention Treatment for Active Ulcerative Colitis

NCT ID: NCT04121806

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2026-09-30

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.

Detailed Description

The etiology of inflammatory bowel disease (IBD), including ulcerative colitis (UC), is complex and poorly understood, but the current hypothesis is that IBD arises from an aberrant immune response to commensal bacteria in a genetically susceptible host, and is triggered by environmental factors. Environmental factors such as the microbiome and diet, play a significant role in the risk of IBD. Diet has been identified as one of the main drivers of the microbiome composition and the microbiome and diet can work in tandem to affect host physiology.

In spite of patient interest in diet and numerous diet studies, currently there is no diet that is clinically validated or universally agreed upon for adult IBD patients. We also lack rigorous studies to show how the microbiome is influenced by diet and affects patient outcomes.

We propose to use a sustainable non-elemental diet aimed at altering the microbiome in patients with mild to moderately active UC to alter their disease activity.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ulcerative colitis patients with mild to moderate activity

Participants will be followed for 14 days on their traditional diet followed by an 8 week intervention with the specially designed and provided treatment diet.

Group Type: EXPERIMENTAL

UC intervention diet

Intervention Type: 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.

Interventions

UC intervention diet

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jenny Lee

Role: CONTACT

jenny.lee@sinaihealth.ca

4165864800 ext. 2318

Joanne Stempak

Role: CONTACT

joanne.stempak@sinaihealth.ca

Facility Contacts

Jenny Lee

Role: primary

jenny.lee@sinaihealth.ca

4165864800 ext. 2318

Other Identifiers

3U01DK062423-18S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0112-A

Identifier Type: -

Identifier Source: org_study_id