Diet with fermented foods for patients with Ulcerative Colitis
Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis
This study is testing if adding fermented foods to the diet can help people with mild to moderate Ulcerative Colitis feel better and reduce inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT04401605 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a diet supplemented with fermented foods on inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). The research aims to address the lack of understanding regarding the relationship between diet and intestinal inflammation. Participants will be assigned to either a fermented food-supplemented diet or a regular diet, and their responses will be monitored through various health metrics. The study seeks to provide insights into how dietary modifications can influence inflammatory markers and overall well-being in UC patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of mild to moderate Ulcerative Colitis.
Not a fit: Patients who are pregnant, have a low body mass index, or have serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of Ulcerative Colitis symptoms and enhanced quality of life for patients.
How similar studies have performed: While there is limited research specifically on fermented foods in UC, similar dietary interventions have shown promise in improving inflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Sidhartha Sinha, MD — Stanford University
- Study coordinator: Touran Fardeen
- Email: tfardeen@stanford.edu
- Phone: 6507367311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.