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NCT Number: NCT04401605

Fermented Food-Supplemented Diet in Ulcerative Colitis

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Diet Modification Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

Location status: Recruiting

Location contact

Touran Fardeen

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fermented Food-supplemented Diet

Other

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

Regular Diet

Other

No change in diet.

Primary outcomes

  1. 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

  1. Clinical response as per partial Mayo score.

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

    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).

  2. Clinical remission as per partial Mayo score.

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

    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).

  3. Symptomatic remission as per Patient Reported Outcome (PRO2) score

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

    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).

  4. Patient global assessment

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

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

  5. Effect of Fermented Food-Supplemented Diet on patient quality of life

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

    Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score. The SIBDQ is a quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).

  6. Changes in cytokines/chemokines and immune cell profiles

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

    Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.

  7. Changes in gut microbiome profiles

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

    Gut microbiome profiles

Study contacts

Contact information is provided by the study sponsor or research team.

Touran Fardeen

CONTACT

[email protected]

6507367311

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
May 26, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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