Fermented Food-Supplemented Diet in Ulcerative Colitis

Stanford University21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Inflammatory Bowel Diseases Diet Modification Ulcerative Colitis

Interventions

Fermented Food-supplemented DietOTHER

Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.

Regular DietOTHER

No change in diet.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

Change in the clinical disease activity inflammatory marker fecal calprotectin

Change in fecal calprotectin

Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).

Secondary Outcomes

Clinical response as per partial Mayo score.

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).

Time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).

Clinical remission as per partial Mayo score.

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).

Time frame: Assessed at Week 10 (Data Collection 2).

Symptomatic remission as per Patient Reported Outcome (PRO2) score

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).

Time frame: Assessed at Week 10 (Data Collection 2).

Patient global assessment

"Do you believe you are in remission from your UC symptoms?" (Yes/No)

Time frame: Assessed at Week 10 (Data Collection 2).

Central Contacts

Touran Fardeen

CONTACT

6507367311 tfardeen@stanford.edu

Data from ClinicalTrials.gov

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