NCT04401605 Fermented Food-Supplemented Diet in Ulcerative Colitis
| NCT ID | NCT04401605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2020-09-14 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 21 participants in total. It began in 2020-09-14 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Sidhartha Sinha, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04401605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04401605 currently recruiting?
Yes, NCT04401605 is actively recruiting participants. Contact the research team at tfardeen@stanford.edu for enrollment information.
Where is the NCT04401605 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT04401605 clinical trial?
NCT04401605 is sponsored by Stanford University. The principal investigator is Sidhartha Sinha, MD at Stanford University. The trial plans to enroll 21 participants.