Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC

NCT06591013 | Completed DMC

• 1 other identifier: FMT-IBD-240710
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), affects over 2 million people worldwide . Although biological therapies have significantly improved the treatment outcomes for UC, nearly two-thirds of patients experience diminishing drug responses over time, making it crucial to explore novel therapeutic approaches targeting the underlying pathophysiology of UC. UC is associated with alterations in gut microbiota, reduced microbial diversity, and changes in the relative abundance of dominant bacterial populations. Specifically, UC patients exhibit a marked decrease in gut microbiota diversity at the species level, with a reduction in Firmicutes (e.g., Clostridium butyricum) and an increase in Actinobacteria, Proteobacteria (e.g., Escherichia coli), Enterobacteriaceae, Streptococcus, and Bacteroides . Given the association between gut microbiota alterations and IBD activity, several studies have proposed microbiota-based therapies, particularly fecal microbiota transplantation (FMT), as a treatment for UC.

Conditions

Inflammatory Bowel Diseases

Keywords

fecal microbiota transplantation（FMT）; the Bai Nationality of Yunnan; Intestinal flora; colonoscope; transendoscopic enteral tubing（TET）; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• a composite of steroid-free clinical remission together with endoscopic remission or response

  total Mayo score of ≤2 points with no individual sub-score \>1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score (MES).

  12 weeks after fecal microbiota transplantation

Secondary Outcomes (8)

• Steroid-free clinical remission

  8 to 12 weeks after fecal microbiota transplantation

• Steroid-free clinical response

  8 to 12 weeks after fecal microbiota transplantation

• Steroid-free endoscopic response

  8 to 12 weeks after fecal microbiota transplantation

• Changes in microbial

  0、1、8、12 weeks after fecal microbiota transplantation

• Duration of microbiota recovery from baseline within groups.

  0、1、8、12 weeks after fecal microbiota transplantation

Study Arms (2)

the Bai nationality-UC

EXPERIMENTAL

Ulcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope

Procedure: Fecal microbiota transplantation

the Han nationality-UC

EXPERIMENTAL

Ulcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope

Procedure: Fecal microbiota transplantation

Interventions

Fecal microbiota transplantation PROCEDURE

Transplantation of fresh fecal bacterial fluid into the ileocecum of patients with ulcerative colitis via the colonoscopic route

the Bai nationality-UC; the Han nationality-UC

Eligibility Criteria

• Age: 14 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 14 and 79 years (inclusive), any gender.
• Diagnosed with ulcerative colitis (UC) per established clinical, endoscopic, and histological standards, with a disease duration of over 3 months.
• Active mild-to-moderate UC, defined by a Mayo score of 4-10, including an endoscopic score ≥1 and a physician's global assessment score ≤2.
• Stable baseline medication consisting of 5-aminosalicylic acid (mesalamine).
• Signed written informed consent.

You may not qualify if:

• Participants unable to provide informed consent, answer questionnaires, or supply samples.
• Pregnant women or those attempting to conceive.
• Participants unwilling to use effective contraception throughout the study.
• Participants deemed in remission by investigators.
• Evidence or history of toxic megacolon.
• Isolated rectal inflammation (\<5 cm in extent).
• Diagnosed with Crohn's disease or indeterminate colitis.
• Participants with perianal diseases (e.g., fistulae, anal fissures).
• History of significant gastrointestinal surgery (e.g., colectomy) ：
• Minor surgeries will be reviewed case by case.
• Patients with appendectomy within 3 months will be excluded.
• Antibiotic use within the past 4 weeks for any reason, including for UC.
• Steroid dependence requiring \>20 mg prednisone or \>9 mg budesonide daily at enrollment.
• Recent or anticipated usage of prohibited drugs during the study period, including:
• Rectal corticosteroids within 2 weeks prior to the first FMT.

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

China

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• L Y Miao, Doctor

  First Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: September 19, 2024
• Study Start: October 14, 2022
• Primary Completion: October 20, 2025
• Study Completion: October 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)