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

NCT07154784 | Enrolling By Invitation Phase 2

• 1 other identifier: 2021-0314
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Co-primary outcome

  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

  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]).

Secondary Outcomes (10)

• Co-secondary 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]).

• Co-secondary 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]).

• Co-secondary 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]).

• Co-secondary 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]).

• Co-secondary 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]).

Study Arms (1)

Ulcerative colitis patient

EXPERIMENTAL

This was a multicenter, prospective study that enrolled patients diagnosed with ulcerative colitis who were aged between 10 and 80 years and had been receiving treatment for at least 3 months. Eligible participants were required to meet all of the following inclusion criteria: 1. age between 10 and 80 years; 2. a disease duration of ulcerative colitis of at least 3 months; 3. mild to moderate disease activity, defined by a Mayo score of 4-10 or a partial Mayo score of 2-7; 4. endoscopic evidence of rectal involvement extending ≥5 cm; and 5. willingness to provide written informed consent for participation in the study.

Biological: Fecal microbiota transplantation (FMT)

Interventions

Fecal microbiota transplantation (FMT) BIOLOGICAL

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).

Ulcerative colitis patient

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 10 and 80 years
• History of ulcerative colitis for at least 3 months
• Mild to moderate ulcerative colitis with a Mayo score of 4-10 or a partial Mayo score of 2-7
• Endoscopic evidence of rectal involvement extending at least 5 cm
• Willingness to provide written informed consent for participation in this clinical trial

You may not qualify if:

• Hospitalization due to acute severe ulcerative colitis (Mayo score 11-12)
• Neutropenia (absolute neutrophil count \< 500)
• Pregnancy
• Infectious colitis not caused by Clostridioides difficile
• History of colectomy (excluding appendectomy)
• History of antibiotic use within the past 2 weeks
• Use of corticosteroids \> 20 mg within the past 4 weeks
• Current or planned use of biologics (e.g., anti-TNF-α antibodies, anti-α4β7 integrin monoclonal antibodies, JAK inhibitors, anti-IL-12/IL-23 antibodies)
• Major food allergy
• Indeterminate colitis
• Comorbid chronic diseases such as chronic liver disease, heart failure, or chronic obstructive pulmonary disease (COPD)
• Refusal to participate in the study
• Any other condition deemed inappropriate for study participation by the investigator

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Inha University Hospital: collaborator
• Seoul National University Boramae Hospital: collaborator

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine

Seoul, Dongjak-gu, 07061, South Korea

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: September 4, 2025
• Study Start: July 19, 2023
• Primary Completion: July 19, 2023
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-08

Locations

KR (1)