Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital of Kunming Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fecal Microbiota Transplantation (FMT)
Biological/VaccineDonor 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Han Donor FMT GroupExperimental treatment 1 intervention
Group B: Dai Donor FMT GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 weeks after the first FMT sessionSecondary outcomes
1
Mayo Score
Change from baseline in total Mayo score (range 0-12, higher scores indicate more severe disease activity).
Time frame
Baseline (1 day pre-FMT), 1 week, and 12 weeks post-FMT2
Mayo Endoscopic Subscore (MES)
Change from baseline in MES (range 0-3, where 0=normal/remission, 1=mild, 2=moderate, 3=severe).
Time frame
Baseline and 12 weeks post-FMT3
Histopathological Assessment by HE Staining
Histological changes in colonic mucosal biopsies assessed by HE staining.
Time frame
Baseline and 12 weeks post-FMT4
Fecal Calprotectin
Change from baseline in fecal calprotectin levels as a marker of intestinal inflammation.
Time frame
Baseline, 1 week, and 12 weeks post-FMTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov