Fermented Food-Supplemented Diet in Ulcerative Colitis
Recruiting · NCT04401605 · Interventional (participants receive a specific treatment) · Lead sponsor: Stanford University
View the official record on ClinicalTrials.gov →Interventions studied
Fermented Food-supplemented DietRegular Diet
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Stanford University - Palo Alto, California, United States