What this study is
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.
What's being tested
- Fermented Food-supplemented Diet
Intervention · OTHER
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
- Regular Diet
Intervention · OTHER
No change in diet.
Study details
- Official title
- Effects of a Fermented Food-Supplemented on Patients with Ulcerative Colitis
- Sponsor
- Stanford University
- Conditions
- Inflammatory Bowel Diseases · Diet Modification · Ulcerative Colitis
- Enrolling
- 21 people
- Starts
- 2020-09-14
- Est. completion
- 2027-06
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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. 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStanford University
Palo Alto, California, United States
- Touran Fardeen · Contacttfardeen@stanford.edu
Recruiting
Study team
Sponsor
Stanford University
Study ID IRB 55558
Principal investigator
Sidhartha Sinha, MD
Stanford University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.