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Diet Intervention Treatment for Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT04121806
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Other: UC intervention diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121806


Contacts
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Contact: Klaudia Rymaszewski 4165864800 ext 2318 klaudia.rymaszewski@sinaihealth.ca

Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Klaudia Rymaszewski    4165864800 ext 2318    klaudia.rymaszewski@sinaihealth.ca   
Principal Investigator: Mark S Silverberg, MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT04121806    
Other Study ID Numbers: 19-0112-A
3U01DK062423-18S1 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases