Fermented Food-Supplemented Diet in Ulcerative Colitis
Not applicable · Testing Fermented Food-supplemented Diet and Regular Diet · 1 site · Stanford University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fermented Food-supplemented Diet and Regular Diet as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases, Diet Modification and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Written informed consent
- Male or female subjects, ≥18 years of age
- Confirmed diagnosis of UC
Plus 2 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 21 participants are expected to take part.
- Start date: 2020-09-14.
- Main results expected around 2026-06-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Change in the clinical disease activity inflammatory marker fecal calprotectin (Baseline (Data Collection 1) versus Week 10 (Data Collection 2).)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Diet Modification; Ulcerative Colitis |
| Lead sponsor | Stanford University |
| Enrollment | 21 (estimated) |
| Start date | 2020-09-14 |
| Primary completion (est.) | 2026-06-30 |
| First posted | 2020-05-26 |
| Last updated | 2026-02-27 |
| Official title | Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT04401605 |
Interventions
- Fermented Food-supplemented Diet (Other)
Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more. - Regular Diet (Other)
No change in diet.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University | Palo Alto, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.