Diet Intervention Treatment for Active Ulcerative Colitis

Diet Intervention as a Prebiotic 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.

Study Overview

• Status: Recruiting
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Other: UC intervention diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Lee; Phone Number: 2318 4165864800; Email: jenny.lee@sinaihealth.ca
• Study Contact Backup: Name: Joanne Stempak; Email: joanne.stempak@sinaihealth.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Jenny Lee; Phone Number: 2318 4165864800; Email: jenny.lee@sinaihealth.ca
      • Principal Investigator: Mark S Silverberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in endoscopic disease activity	measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual	10 weeks
Decrease in clinical disease activity	measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual	10 weeks

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 19-0112-A; 3U01DK062423-18S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No