Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This randomized, parallel‐group clinical study investigates the efficacy and mechanismsof fecal microbiota transplantation (FMT) using healthy donors from the Dai nationalityversus Han nationality for treating ulcerative colitis (UC).Background: UC is a chronic relapsing inflammatory bowel disease characterized by colonicmucosal inflammation. FMT has emerged as a promising therapeutic strategy byreconstructing intestinal microbiota. Preliminary findings indicate that FMT using donorsfrom the Dai ethnic group in Yunnan Province (who have unique dietary and lifestylehabits) may achieve superior clinical remission compared to Han donors. This study aimsto validate this observation and identify the core metabolites and key gut microbiotaresponsible for the enhanced efficacy.Study Design: A total of 200 UC patients (aged 18‐60 years, Mayo score 3‐10, left‐sidedcolitis) will be enrolled and randomly allocated into two groups (n=100 each): (1) FMTwith healthy Han donors; (2) FMT with healthy Dai donors. Donors will be healthyindividuals aged 18‐23 years screened according to AGA guidelines.Intervention: Patients will receive FMT via transendoscopic enteral tubing (TET) at 60 mLper infusion, once every 3 days for a total of 3 times.Outcome Measures: Primary efficacy is clinical remission at week 12 (Mayo total score ≤2,no individual subscore >1, endoscopic subscore decreased by ≥1 from baseline). Secondaryendpoints include Mayo score, MES, histopathology (HE staining), fecal calprotectin, CRP,ESR, and intestinal mucosal barrier function.Mechanistic Investigations: Donor and recipient stool samples will be collected beforeFMT and at weeks 1 and 12 post‐FMT. Metabolomics (LC‐MS/MS, GC‐MS) and metagenomicsequencing will identify differential metabolites and key bacterial taxa. Co‐occurrenceand metabolic complementarity networks will identify keystone species. Correlationanalysis will reveal functional microbial groups. In vitro and in vivo experiments willvalidate the anti‐inflammatory effects of identified key bacteria and metabolites.Significance: This study will elucidate why Dai donors may confer superior FMT outcomesand identify transplantable microbial signatures and bioactive metabolites for UCtherapy.
Epistemonikos ID: b36e96e910fea5dfd2b043ab2e6396ce09b7db05
First added on: Sep 12, 2026