Recruiting

Fermented Food

Sponsor:

Stanford University

Code:

NCT04401605

Conditions

Inflammatory Bowel Diseases

Diet Modification

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fermented Food-supplemented Diet

Regular Diet

Study Details

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

Study ID

NCT04401605

Start date

Sep 14, 2020

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Fermented Food-supplemented Diet

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

Regular Diet

No change in diet.

Primary outcome measure

  • Change in the clinical disease activity inflammatory marker fecal calprotectin [ Time Frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2). ]

Central Contacts and Locations

Central contacts

Touran Fardeen

6507367311tfardeen@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Touran Fardeen

tfardeen@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • IBD
  • Ulcerative Colitis
  • UC
  • Diet
  • Fermented Food

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-27.