Status:
RECRUITING
Fermented Food-Supplemented Diet in Ulcerative Colitis
Lead Sponsor:
Stanford University
Conditions:
Inflammatory Bowel Diseases
Diet Modification
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04401605
Start Date
September 14 2020
End Date
June 1 2027
Last Update
November 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Palo Alto, California, United States, 94305