Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors

NCT07814456 | Recruiting Phase 2

• 1 other identifier: FMT-IBD-260701
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis (UC); Inflammatory Bowel Disease

Keywords

Fecal microbiota transplantation; Ulcerative colitis; Inflammatory bowel disease; Dai donors; Han donors; Gut microbiota; Clinical efficacy

Outcome Measures

Primary Outcomes (1)

• Rate of clinical and endoscopic remission at 12 weeks

  Proportion of ulcerative colitis patients achieving both clinical and endoscopic remission at 12 weeks after fecal microbiota transplantation (FMT) without corticosteroid use. Clinical remission is defined as a total Mayo score ≤2 with no individual subscore \>1. Endoscopic improvement is defined as a decrease in the Mayo Endoscopic Subscore (MES) of at least 1 point from baseline. Patients must achieve both criteria simultaneously.

  12 weeks after the first FMT session

Secondary Outcomes (7)

• Mayo Score

  Baseline (1 day pre-FMT), 1 week, and 12 weeks post-FMT

• Mayo Endoscopic Subscore (MES)

  Baseline and 12 weeks post-FMT

• Histopathological Assessment by HE Staining

  Baseline and 12 weeks post-FMT

• Fecal Calprotectin

  Baseline, 1 week, and 12 weeks post-FMT

• C-Reactive Protein (CRP)

  Baseline, 1 week, and 12 weeks post-FMT

Study Arms (2)

Han Donor FMT Group

EXPERIMENTAL

Patients with ulcerative colitis (UC) receive fecal microbiota transplantation (FMT) from healthy Han donors aged 18-23 years. FMT is administered via transendoscopic enteral tubing (TET) at 60 mL per session, once every 3 days, for a total of 3 sessions. Only mesalazine is used before and after FMT to exclude drug interference. Clinical efficacy will be evaluated at 12 weeks post-FMT.

Biological: Fecal Microbiota Transplantation (FMT)

Dai Donor FMT Group

EXPERIMENTAL

Patients with ulcerative colitis (UC) receive fecal microbiota transplantation (FMT) from healthy Dai donors aged 18-23 years from Xishuangbanna, Yunnan. FMT is administered via transendoscopic enteral tubing (TET) at 60 mL per session, once every 3 days, for a total of 3 sessions. Only mesalazine is used before and after FMT to exclude drug interference. Clinical efficacy will be evaluated at 12 weeks post-FMT.

Biological: Fecal Microbiota Transplantation (FMT)

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.

Also known as: FMT; Microbiota transfer

Dai Donor FMT Group; Han Donor FMT Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Kunming Medical University First Affiliated Hospital

Kunming, Yunnan, 650032, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Yinglei Miao, MD

  Kunming Medical University First Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zihong Chen

CONTACT

+86 18388452165; chenzihong2018@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study. Both participants and care providers are aware of the donor group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Department of Gastroenterology

Model Details: Patients with ulcerative colitis are randomly assigned to receive fecal microbiota transplantation (FMT) from either Dai donors or Han donors in a parallel group design.

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 11, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

CN (1)