RecruitingPhase 2NCT07814456

Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors

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


Sponsor

First Affiliated Hospital of Kunming Medical University

Enrollment

200 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Fecal Microbiota Transplantation (FMT) for people with inflammatory bowel disease and ulcerative colitis (uc). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFecal Microbiota Transplantation (FMT)

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.


Locations(1)

Kunming Medical University First Affiliated Hospital

Kunming, Yunnan, China

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NCT07814456


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