Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment … (NCT06591013) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC
China102 participantsStarted 2022-10-14
Plain-language 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.
Who can participate
Age range14 Years – 79 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
a composite of steroid-free clinical remission together with endoscopic remission or response
Timeframe: 12 weeks after fecal microbiota transplantation
Trial details
NCT IDNCT06591013
SponsorFirst Affiliated Hospital of Kunming Medical University