NCT06591013

Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC

Research on the Mechanisms of Different Donors in Fecal Microbiota Transplantation for Treating Ulcerative Colitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: First Affiliated Hospital of Kunming Medical University · Academic / Other
• Sex: All
• Age: 14 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

FMT involves the infusion of fecal material from healthy donors into patients to restore gut microbiota balance. It is currently recognized as an effective treatment for recurrent or refractory Clostridium difficile infections. Numerous studies suggest that FMT, as a therapeutic tool to regulate gut microbial homeostasis, holds potential in treating UC and other diseases, although the biochemical and/or immune mechanisms underlying its effects remain unclear . Paramsothy et al. demonstrated the efficacy of autologous FMT compared to placebo, utilizing a protocol involving colonoscopy-guided FMT followed by daily enemas for 5 days per week over 8 weeks. However, the high financial burden of this approach limits its broader clinical application. Another study revealed that donor FMT prepared anaerobically for 1-week treatment led to a higher likelihood of remission at 8 weeks compared to autologous FMT. Further research is needed to assess its safety and maintain long-term remission rates. Our team's high-quality research findings indicate that the gut microbiota of populations in Yunnan's ethnic minority regions exhibits significantly higher diversity and regional specificity compared to urban populations. This has potential value in enhancing FMT efficacy. Previous studies revealed ethnic and regional differences in IBD prevalence in Yunnan Province, with lower rates among the Dai, Bai, and Miao ethnic groups compared to the Han population. An analysis of contributing factors highlighted the protective role of traditional ethnic diets, which increase gut microbial and viral diversity and probiotics content, thereby reducing UC prevalence. Based on this, the differences between donors in FMT may affect treatment outcomes, emphasizing the importance of identifying "high-quality" donors who maximize efficacy and minimize adverse reactions.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
PROCEDURE	Fecal microbiota transplantation	Transplantation of fresh fecal bacterial fluid into the ileocecum of patients with ulcerative colitis via the colonoscopic route

Timeline

• Start date: 2022-10-14
• Primary completion: 2025-10-20
• Completion: 2025-10-31
• First posted: 2024-09-19
• Last updated: 2026-04-13

Locations

1 site across 1 country: China