Fermented Food-Supplemented Diet in Ulcerative Colitis

Last updated: November 25, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Crohn's Disease

Inflammatory Bowel Disease

Treatment

Regular Diet

Fermented Food-supplemented Diet

Clinical Study ID

NCT04401605
IRB 55558
  • Ages > 18
  • All Genders

Study 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

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

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 writingby a physician)

  • Individuals who have been severely weakened by a disease or medical procedure

  • Individuals with more than mild-moderate cardiovascular disease or life-threateningcancer (as determined by patient's physician) unless approved by a physician

  • Individuals with history of severe cardiac disease (particularly uncompensatedcongestive 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

Total Participants: 21
Treatment Group(s): 2
Primary Treatment: Regular Diet
Phase:
Study Start date:
September 14, 2020
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Stanford University

    Palo Alto, California 94305
    United States

    Active - Recruiting

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