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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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.

Eligibility

Primary outcome measure(s)

• Co-primary outcome — The disease status will be evaluated at week 12 as the final assessment. Long-term efficacy and safety will also be analyzed at week 48(e.g., History of hospitalization, mortality, occurrence of malignant tumors, and adverse events[Safety]).
  1. Steroid-free Clinical Response at Week 12 Mayo score ≥3 and ≥30% ↓ from baseline, with rectal bleeding subscore ↓ ≥1 or ≤1, without steroid use. Unit: Participants 2. Steroid-free Clinical Remission at Week 12 Mayo score ≤2 and no subscore \>1, without steroid use. Unit: Participants

Trial sites (1)

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