Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

NCT07154784 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-12

No results posted yet for this study

Summary

This study aims to perform fecal microbiota transplantation (FMT) and analyze its effects in selected patients aged between 10 and 80 years who have been diagnosed with ulcerative colitis and have been receiving treatment for more than three months at Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this analysis, the study seeks to identify the long-term efficacy of FMT as a treatment for ulcerative colitis, evaluate the safety of the procedure, and establish a foundation for personalized FMT based on gut microbiota analysis.

Conditions

Interventions

BIOLOGICAL

Fecal microbiota transplantation (FMT)

Fecal microbiota transplantation (FMT) will be performed at weeks 0 and 4 of study enrollment by administering approximately 250-300 cc of a multi-donor fecal suspension into the colon via sigmoidoscopy, colonoscopy, or by oral administration of an equivalent amount (4 capsules).

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER
  • Inha University Hospital

    collaborator OTHER
  • Seoul National University Boramae Hospital

    collaborator OTHER
  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-19
Primary Completion
2023-07-19
Completion
2027-06-30

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154784 on ClinicalTrials.gov