Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis
Status:
Completed
Trial end date:
2022-01-10
Target enrollment:
Participant gender:
Summary
Ulcerative colitis (UC) is a chronic immune-mediated inflammatory bowel disease (IBD) that
almost always affects the rectum and often extends to the more proximal colon. UC usually
begins at a young age (15-30 years), most patients (~ 85%) have a mild or moderate activity,
characterized by periods of exacerbation and remission. Considering the important
pathogenetic role of gut dysbiosis, recently, as an additional method of treating UC, it is
considered a modification of altered gut microbiota using various drug and non-drug methods.
One such method is fecal microbiota transplantation (FMT), consisting of the simultaneous
replacement of the gut microbiota of a sick recipient with fecal material from a healthy
donor. Even though so far the only officially approved indication for FMT is recurrent
Clostridium difficile infection, however, the effectiveness of FMT is currently being studied
in the treatment of other gastrointestinal and non-gastrointestinal pathologies, including
UC. To date, several controlled and uncontrolled studies have been conducted to study the
effectiveness of FMT in UC, showing encouraging results. This study aimed to assess the
clinical and microbiological efficacy, tolerability, and safety of FMT as add-on therapy to
basic therapy, in patients with mild-to-moderate UC.
Phase:
N/A
Details
Lead Sponsor:
Bogomolets National Medical University
Collaborator:
Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine