Fermented Food-Supplemented Diet in Ulcerative Colitis

NCT04401605 | Recruiting

• 1 other identifier: IRB 55558
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Diet Modification; Ulcerative Colitis

Keywords

IBD; Ulcerative Colitis; UC; Diet; Fermented Food

Outcome Measures

Primary Outcomes (1)

• Change in the clinical disease activity inflammatory marker fecal calprotectin

  Change in fecal calprotectin

  Baseline (Data Collection 1) versus Week 10 (Data Collection 2).

Secondary Outcomes (7)

• Clinical response as per partial Mayo score.

  Baseline (Data Collection 1) versus Week 10 (Data Collection 2).

• Clinical remission as per partial Mayo score.

  Assessed at Week 10 (Data Collection 2).

• Symptomatic remission as per Patient Reported Outcome (PRO2) score

  Assessed at Week 10 (Data Collection 2).

• Patient global assessment

  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).

Study Arms (2)

Fermented Food-Supplemented Diet

EXPERIMENTAL

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.

Other: Fermented Food-supplemented Diet

Regular Diet Control Arm

PLACEBO COMPARATOR

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.

Other: Regular Diet

Interventions

Fermented Food-supplemented Diet OTHER

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

Fermented Food-Supplemented Diet

Regular Diet OTHER

No change in diet.

Regular Diet Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Diet

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sidhartha Sinha, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Touran Fardeen

CONTACT

6507367311; tfardeen@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Gastroenterology and Hepatology)

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: September 14, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)