Fecal Transplants from Dai vs Han Donors for Ulcerative Colitis
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
Run by First Affiliated Hospital of Kunming Medical University · NCT07814456 · Data updated 2026-11-12
This study tests whether fecal microbiota transplantation from healthy Dai donors improves symptoms in adults with ulcerative colitis more than transplantation from healthy Han donors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | First Affiliated Hospital of Kunming Medical University Academic / other |
| Locations | 1 site (Kunming, Yunnan) |
| Status | Recruiting |
| Started | February 3, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07814456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with left-sided ulcerative colitis, Mayo score 3–10, previously treated with mesalazine.
✕Probably not a fit
Patients with mild disease (Mayo ≤2) or those not responding to FMT in this trial may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 2 randomized trial comparing two donor groups for FMT in ulcerative colitis. Two parallel arms (Han donors vs Dai donors) will each enroll 100 adults with left-sided colitis and a Mayo score of 3–10, receiving three FMT infusions via endoscopic tubing every three days. The primary goal is to see if 12-week clinical remission (Mayo score ≤2 with no subscore >1 and reduced endoscopic score) is achieved, while secondary outcomes include changes in Mayo score, MES, and histology. Donors are screened healthy individuals aged 18–23, using standard guidelines. The study seeks to understand microbiota and metabolite factors that may drive efficacy and safety.
Why it matters
Potential benefit: If successful, patients may achieve higher rates of remission and improved gut healing using donor types that confer greater therapeutic benefit.
How similar studies have gone: Prior observations suggested Dai donor FMT could lead to better remission rates; this trial seeks to validate and understand the mechanism.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Kunming Medical University First Affiliated Hospital
Kunming, Yunnan, China Recruiting
Study contacts
- Principal investigator: Yinglei Miao, MD — Kunming Medical University First Affiliated Hospital
- Study coordinator: Zihong Chen
- Email: chenzihong2018@163.com
- Phone: +86 18388452165
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.