Diet Intervention Treatment for Active Ulcerative Colitis
Primary Purpose
Colitis, Ulcerative
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
UC intervention diet
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative
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.
Sites / Locations
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ulcerative colitis patients with mild to moderate activity
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in microbiome composition
measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual
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
Secondary Outcome Measures
Decrease in endoscopic disease activity
measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual
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
Full Information
NCT ID
NCT04121806
First Posted
September 30, 2019
Last Updated
September 12, 2022
Sponsor
Mount Sinai Hospital, Canada
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04121806
Brief Title
Diet Intervention Treatment for Active Ulcerative Colitis
Official Title
Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ulcerative colitis patients with mild to moderate activity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
UC intervention diet
Intervention Description
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 Information:
Title
Change in microbiome composition
Description
measured by 16S rDNA sequencing and comparing pretreatment diet and the treatment diet within an individual
Time Frame
10 weeks
Title
Change in microbiome function
Description
measured by shotgun sequencing and comparing difference in enriched functional pathways between pretreatment diet and the treatment diet within an individual
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Decrease in endoscopic disease activity
Description
measured by a decrease in Mayo score between pretreatment diet and the treatment diet within an individual
Time Frame
10 weeks
Title
Decrease in clinical disease activity
Description
measured by a decrease in serum C-reactive protein (CRP) levels between pretreatment diet and the treatment diet within an individual
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Lee
Phone
4165864800
Ext
2318
Email
jenny.lee@sinaihealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Stempak
Email
joanne.stempak@sinaihealth.ca
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Lee
Phone
4165864800
Ext
2318
Email
jenny.lee@sinaihealth.ca
First Name & Middle Initial & Last Name & Degree
Mark S Silverberg, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Diet Intervention Treatment for Active Ulcerative Colitis
We'll reach out to this number within 24 hrs