Clinical trial NCT04401605: Fermented Food-Supplemented Diet in Ulcerative Colitis
Official title: Effects of a Fermented Food-Supplemented on Patients with Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Diet Modification
Ulcerative Colitis
Keywords: IBD
Ulcerative Colitis
UC
Diet
Fermented Food
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the clinical disease activity inflammatory marker fecal calprotectin
timeFrame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Secondary outcomes:
measure: Clinical response as per partial Mayo score.
timeFrame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
measure: Clinical remission as per partial Mayo score.
timeFrame: Assessed at Week 10 (Data Collection 2).
measure: Symptomatic remission as per Patient Reported Outcome (PRO2) score
timeFrame: Assessed at Week 10 (Data Collection 2).
measure: Patient global assessment
timeFrame: Assessed at Week 10 (Data Collection 2).
measure: Effect of Fermented Food-Supplemented Diet on patient quality of life
timeFrame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
measure: Changes in cytokines/chemokines and immune cell profiles
timeFrame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
measure: Changes in gut microbiome profiles
timeFrame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sidhartha Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References: