Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04121806

Diet Intervention Treatment for Active Ulcerative Colitis

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location status: Recruiting

Location contact

Jenny Lee

CONTACT

[email protected]

4165864800 ext. 2318

Mark S Silverberg, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in microbiome composition

    Time frame: 10 weeks

    measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual

  2. Change in microbiome function

    Time frame: 10 weeks

    measured by shotgun sequencing and comparing difference in enriched functional pathways between pretreatment diet and the treatment diet within an individual

Secondary outcomes

  1. Decrease in endoscopic disease activity

    Time frame: 10 weeks

    measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual

  2. Decrease in clinical disease activity

    Time frame: 10 weeks

    measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Lee

CONTACT

[email protected]

4165864800 ext. 2318

Joanne Stempak

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

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

Registry information

Official study title

Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2019
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.