- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04401605
Fermented Food-Supplemented Diet in Ulcerative Colitis
May 16, 2023 updated by: Sidhartha Ranjit Sinha, Stanford University
Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis
The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC).
There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation.
Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Touran Fardeen
- Phone Number: 6507367311
- Email: tfardeen@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Touran Fardeen
- Email: tfardeen@stanford.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Written informed consent
- Male or female subjects, ≥18 years of age
- Confirmed diagnosis of UC
- Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)
- Elevated fecal calprotectin
Exclusion Criteria:
- Women who are pregnant, nursing or expect to be pregnant
- Intolerance to fermented food
- Individuals with a body mass index (BMI) lower than 18
- Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)
- Individuals who have been severely weakened by a disease or medical procedure
- Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
- Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF < 40%)
- History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.
Complications of disease such as extraintestinal manifestations (EIMs) are not automatically considered exclusion criteria. Appropriate medical treatment for UC and/or EIMs will not be withheld.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fermented Food-Supplemented Diet
Patients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks.
|
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
|
Placebo Comparator: Regular Diet Control Arm
Patients in this arm will continue their regular diet throughout the 10 weeks of study with a maximum of 1 serving of fermented foods per day.
|
No change in diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the clinical disease activity inflammatory marker fecal calprotectin
Time Frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Change in fecal calprotectin
|
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response as per partial Mayo score.
Time Frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Clinical response as per partial Mayo score is defined as a decrease from baseline in the partial Mayo Score of >=2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point (assessed at Data Collection 2).
The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy.
Each subscore is graded from 0 to 3 (3 being the worst situation and 0 the best) and the partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
|
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Clinical remission as per partial Mayo score.
Time Frame: Assessed at Week 10 (Data Collection 2).
|
Clinical remission as per partial Mayo score is defined as a partial Mayo score < 2 points and no individual subscale score >1 point (assessed at Data Collection 2).
The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
|
Assessed at Week 10 (Data Collection 2).
|
Symptomatic remission as per Patient Reported Outcome (PRO2) score
Time Frame: Assessed at Week 10 (Data Collection 2).
|
Symptomatic remission is defined as as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0 (assessed at Data Collection 2).
The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
|
Assessed at Week 10 (Data Collection 2).
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Patient global assessment
Time Frame: Assessed at Week 10 (Data Collection 2).
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"Do you believe you are in remission from your UC symptoms?"
(Yes/No)
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Assessed at Week 10 (Data Collection 2).
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Effect of Fermented Food-Supplemented Diet on patient quality of life
Time Frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score.
The SIBDQ is a quality of life score in UC patients.
Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).
|
Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Changes in cytokines/chemokines and immune cell profiles
Time Frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Cytokines/chemokines (e.g.
TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.
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Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
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Changes in gut microbiome profiles
Time Frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Gut microbiome profiles
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Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sidhartha Sinha, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2020
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
June 1, 2025
Study Registration Dates
First Submitted
May 20, 2020
First Submitted That Met QC Criteria
May 20, 2020
First Posted (Actual)
May 26, 2020
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 16, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 55558
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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