NCT07814456 Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors
| NCT ID | NCT07814456 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Kunming Medical University |
| Condition | Ulcerative Colitis (UC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2029-12-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2026-02-03 with a primary completion date of 2029-12-31.
⚠ 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
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. FMT transfers gut bacteria from a healthy donor to a patient to restore healthy intestinal microbiota. Previous research suggested that FMT using donors from the Dai ethnic group (a minority nationality in Yunnan with special dietary habits) may achieve better results than Han Chinese donors for UC. This study aims to confirm this finding and understand why. The investigators will recruit 200 UC patients (ages 18-60) and randomly assign them to two groups (100 each). One group will receive FMT from healthy Han donors; the other from healthy Dai donors. Patients will receive three FMT infusions via endoscopic intestinal tubing. Treatment effects will be assessed at 12 weeks using clinical scores (Mayo score), endoscopic scores (MES), inflammatory markers (fecal calprotectin, CRP, ESR), and intestinal barrier function tests. Stool samples will also be analyzed using metabolomics and metagenomics to identify key gut bacteria and metabolites linked to better outcomes, and laboratory experiments will be performed to verify how they reduce intestinal inflammation. The goal is to identify optimal donor characteristics for FMT in UC and uncover mechanisms that may lead to more personalized microbiota therapies.
Eligibility 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
Contact & Investigator
Yinglei Miao, MD
PRINCIPAL INVESTIGATOR
Kunming Medical University First Affiliated Hospital
Frequently Asked Questions
Who can join the NCT07814456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Ulcerative Colitis (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07814456 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07814456 currently recruiting?
Yes, NCT07814456 is actively recruiting participants. Contact the research team at chenzihong2018@163.com for enrollment information.
Where is the NCT07814456 trial being conducted?
This trial is being conducted at Kunming, China.
Who is sponsoring the NCT07814456 clinical trial?
NCT07814456 is sponsored by First Affiliated Hospital of Kunming Medical University. The principal investigator is Yinglei Miao, MD at Kunming Medical University First Affiliated Hospital. The trial plans to enroll 200 participants.
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