Effects of a Fermented Food-Supplemented on Patients with Ulcerative Colitis

Stanford University1 site in 1 country21 target enrollmentSeptember 14, 2020

ConditionsInflammatory Bowel Diseases Diet Modification Ulcerative Colitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Bowel Diseases
Sponsor: Stanford University
Enrollment: 21
Locations: 1
Primary Endpoint: Change in the clinical disease activity inflammatory marker fecal calprotectin
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 14, 2020

End Date

June 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Sidhartha Ranjit Sinha

Assistant Professor of Medicine (Gastroenterology and Hepatology)

Stanford University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Clinical remission as per partial Mayo score.(Assessed at Week 10 (Data Collection 2).)
Clinical response as per partial Mayo score.(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
Patient global assessment(Assessed at Week 10 (Data Collection 2).)
Changes in cytokines/chemokines and immune cell profiles(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
Symptomatic remission as per Patient Reported Outcome (PRO2) score(Assessed at Week 10 (Data Collection 2).)
Effect of Fermented Food-Supplemented Diet on patient quality of life(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
Changes in gut microbiome profiles(Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)