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Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors

11 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Yunnan
      • Kunming, Yunnan, Chine, 650032
        • Recrutement
        • Kunming Medical University First Affiliated Hospital
        • Contact:
          • Zihong Chen, MD
        • Chercheur principal:
          • Yinglei Miao, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: 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.
Autres noms:
  • FMT; Microbiota transfer
Expérimental: 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.
Biologique: 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.
Autres noms:
  • FMT; Microbiota transfer

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Rate of clinical and endoscopic remission at 12 weeks
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mayo Score
Délai: 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)
Délai: 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
Délai: Baseline and 12 weeks post-FMT
Histological changes in colonic mucosal biopsies assessed by HE staining.
Baseline and 12 weeks post-FMT
Fecal Calprotectin
Délai: 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)
Délai: 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)
Délai: 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
Délai: Baseline and 12 weeks post-FMT
Assessment of intestinal mucosal barrier function in UC patients after FMT.
Baseline and 12 weeks post-FMT

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

First Affiliated Hospital of Kunming Medical University

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 février 2026

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

30 août 2026

Première soumission répondant aux critères de contrôle qualité

5 septembre 2026

Première publication (Réel)

11 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FMT-IBD-260701

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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