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Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors

11 september 2026 bijgewerkt door: Yinglei Miao, First Affiliated Hospital of Kunming Medical University

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This randomized, parallel-group clinical study investigates the efficacy and mechanisms of fecal microbiota transplantation (FMT) using healthy donors from the Dai nationality versus Han nationality for treating ulcerative colitis (UC).

Background: UC is a chronic relapsing inflammatory bowel disease characterized by colonic mucosal inflammation. FMT has emerged as a promising therapeutic strategy by reconstructing intestinal microbiota. Preliminary findings indicate that FMT using donors from the Dai ethnic group in Yunnan Province (who have unique dietary and lifestyle habits) may achieve superior clinical remission compared to Han donors. This study aims to validate this observation and identify the core metabolites and key gut microbiota responsible for the enhanced efficacy.

Study Design: A total of 200 UC patients (aged 18-60 years, Mayo score 3-10, left-sided colitis) will be enrolled and randomly allocated into two groups (n=100 each): (1) FMT with healthy Han donors; (2) FMT with healthy Dai donors. Donors will be healthy individuals aged 18-23 years screened according to AGA guidelines.

Intervention: Patients will receive FMT via transendoscopic enteral tubing (TET) at 60 mL per 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). Secondary endpoints 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 before FMT and at weeks 1 and 12 post-FMT. Metabolomics (LC-MS/MS, GC-MS) and metagenomic sequencing will identify differential metabolites and key bacterial taxa. Co-occurrence and metabolic complementarity networks will identify keystone species. Correlation analysis will reveal functional microbial groups. In vitro and in vivo experiments will validate the anti-inflammatory effects of identified key bacteria and metabolites.

Significance: This study will elucidate why Dai donors may confer superior FMT outcomes and identify transplantable microbial signatures and bioactive metabolites for UC therapy.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Werving
        • Kunming Medical University First Affiliated Hospital
        • Contact:
          • Zihong Chen, MD
        • Hoofdonderzoeker:
          • Yinglei Miao, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Han Donor FMT Group
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.
Biologisch: Fecal 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.
Andere namen:
  • FMT; Microbiota transfer
Experimenteel: Dai Donor FMT Group
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.
Biologisch: Fecal 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.
Andere namen:
  • FMT; Microbiota transfer

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of clinical and endoscopic remission at 12 weeks
Tijdsspanne: 12 weeks after the first FMT session
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mayo Score
Tijdsspanne: Baseline (1 day pre-FMT), 1 week, and 12 weeks post-FMT
Change from baseline in total Mayo score (range 0-12, higher scores indicate more severe disease activity).
Baseline (1 day pre-FMT), 1 week, and 12 weeks post-FMT
Mayo Endoscopic Subscore (MES)
Tijdsspanne: Baseline and 12 weeks post-FMT
Change from baseline in MES (range 0-3, where 0=normal/remission, 1=mild, 2=moderate, 3=severe).
Baseline and 12 weeks post-FMT
Histopathological Assessment by HE Staining
Tijdsspanne: Baseline and 12 weeks post-FMT
Histological changes in colonic mucosal biopsies assessed by HE staining.
Baseline and 12 weeks post-FMT
Fecal Calprotectin
Tijdsspanne: Baseline, 1 week, and 12 weeks post-FMT
Change from baseline in fecal calprotectin levels as a marker of intestinal inflammation.
Baseline, 1 week, and 12 weeks post-FMT
C-Reactive Protein (CRP)
Tijdsspanne: Baseline, 1 week, and 12 weeks post-FMT
Change from baseline in serum CRP levels.
Baseline, 1 week, and 12 weeks post-FMT
Erythrocyte Sedimentation Rate (ESR)
Tijdsspanne: Baseline, 1 week, and 12 weeks post-FMT
Change from baseline in ESR.
Baseline, 1 week, and 12 weeks post-FMT
Intestinal Mucosal Barrier Function
Tijdsspanne: Baseline and 12 weeks post-FMT
Assessment of intestinal mucosal barrier function in UC patients after FMT.
Baseline and 12 weeks post-FMT

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

First Affiliated Hospital of Kunming Medical University

Onderzoekers

  • Hoofdonderzoeker: Yinglei Miao, MD, Kunming Medical University First Affiliated Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 februari 2026

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

30 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 september 2026

Eerst geplaatst (Werkelijk)

11 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

11 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FMT-IBD-260701

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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