Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors
Phase 2 · Testing Fecal Microbiota Transplantation (FMT) · 1 site · First Affiliated Hospital of Kunming Medical University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota Transplantation (FMT) (a biologic) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC) and Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 60
- Any sex
Some of the main requirements, copied from the record:
- Age 18-60 years
- Diagnosed with ulcerative colitis (left-sided colitis) according to ECCO guidelines and Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 Xi'an)
- Baseline Mayo score 3-10
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2026-02-03.
- Main results expected around 2029-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Rate of clinical and endoscopic remission at 12 weeks (12 weeks after the first FMT session)
In the researchers’ words
This study is a randomized clinical trial evaluating fecal microbiota transplantation (FMT) for ulcerative colitis (UC) using healthy donors from two ethnic groups in Yunnan, China. UC is a chronic inflammatory bowel disease causing colon inflammation and ulcers.
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 | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Inflammatory Bowel Disease |
| Lead sponsor | First Affiliated Hospital of Kunming Medical University |
| Enrollment | 200 (estimated) |
| Start date | 2026-02-03 |
| Primary completion (est.) | 2029-12-31 |
| First posted | 2026-09-11 |
| Last updated | 2026-09-15 |
| Official title | Fecal Microbiota Transplantation for Ulcerative Colitis Using Healthy Donors From Yunnan Dai and Han Nationalities: A Randomized Study to Screen Core Metabolites and Key Microbiota |
| ClinicalTrials.gov ID | NCT07814456 |
Interventions
- Fecal Microbiota Transplantation (FMT) (Biological)
Donor stool (60 g) is processed using the CleanFMT method with GenFMTer system, including filtration, centrifugation, washing, and resuspension in sterile normal saline (1.5× volume). The final product is 200 mL fecal suspension, administered via TET at 60 mL per session, once every 3 days, for 3 sessions total.
Full eligibility criteria (from the record)
Inclusion Criteria: * Age 18-60 years * Diagnosed with ulcerative colitis (left-sided colitis) according to ECCO guidelines and Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 Xi'an) * Baseline Mayo score 3-10 * Treated only with mesalazine before and during the study to exclude drug interference Exclusion Criteria: * Pregnancy or planned pregnancy in the near future * Patients in clinical remission (Mayo score ≤2 with no individual subscore >1) * Development of diseases different from or confounding the initial diagnosis during the study * History of toxic megacolon, perianal disease, or intestinal surgery * Concurrent severe cardiac, pulmonary, or renal disease, or malignancy
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Kunming Medical University First Affiliated Hospital | Kunming, Yunnan | China | 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.