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Enrolling by invitationPhase 2/3

Tests fecal microbiota transplantation for long-term ulcerative colitis treatment

Tests stool bacteria transplant in people aged 10 to 80 with ulcerative colitis.

Plain-language title generated from the registry record
Registry title: Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

Key facts

Where
Seoul, South KoreaSee the site
Phase
Phase 2/3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 80 years old?

Source: NCT07154784, who can take part

Where in South Korea

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of MedicineSeoul, South KoreaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Seoul National University Hospital
Trial code
NCT07154784
Record updated
12 September 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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); History of colectomy (excluding appendectomy); History of antibiotic use within the past 2 weeks; Major food allergy; Comorbid chronic diseases such as chronic liver disease, heart failure, or chronic obstructive pulmonary disease (COPD); Any other condition deemed inappropriate for study participation by the investigator; Neutropenia (absolute neutrophil count < 500); Hospitalization due to acute severe ulcerative colitis (Mayo score 11-12); Pregnancy; Infectious colitis not caused by Clostridioides difficile; Indeterminate colitis; Refusal to participate in the study.

ClinicalTrials.gov NCT07154784