NCT05538026

Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis

Efficacy and Safety of Fecal Microbiota Transplantation as add-on Therapy in Patients With Mild-To-Moderate Ulcerative Colitis: A Randomized, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Bogomolets National Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis Chronic Mild
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	Mesalazine	daily dose of 3 g (2 g orally + 1 g rectally)
BIOLOGICAL	Fecal transplantation	Preparation of fresh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of UC patient by colonoscopy after standard bowel preparation.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-01-01
• Completion: 2022-01-10
• First posted: 2022-09-13
• Last updated: 2022-09-13

Locations

2 sites across 1 country: Ukraine