Recruiting

Diet Intervention

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT04121806

Conditions

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

UC intervention diet

Study Details

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.

Conditions

Colitis, Ulcerative

Study ID

NCT04121806

Start date

Mar 1, 2021

Status verified date

Sep, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Change in microbiome composition [ Time Frame: 10 weeks ]
  • Change in microbiome function [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Jenny Lee

4165864800jenny.lee@sinaihealth.ca

Joanne Stempak

joanne.stempak@sinaihealth.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Jenny Lee

4165864800jenny.lee@sinaihealth.ca

Principal Investigator:

Mark S Silverberg, MD

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2025-09-29.