NCT05538026

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

Completed NA Last updated 13 September 2022

What this trial tests

NA trial testing Mesalazine in Ulcerative Colitis Chronic Mild in 53 participants. Completed in 10 January 2022.

Timeline

1 September 2020

Primary endpoint
1 January 2022

10 January 2022

Quick facts

Lead sponsor	Bogomolets National Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	1 September 2020
Primary completion	1 January 2022
Estimated completion	10 January 2022
Sites	2 locations across Ukraine

Drugs / interventions tested

• Mesalazine (Mesalazine) — full drug profile →
• Fecal transplantation — full drug profile →

Conditions studied

• Ulcerative Colitis Chronic Mild — all drugs for Ulcerative Colitis Chronic Mild →
• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

Bogomolets National Medical University

Who can join

Adults 18 to 60, any sex, with Ulcerative Colitis Chronic Mild or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiota in pathophysiology, diagnosis, and therapeutics of inflammatory bowel disease.
   Pandey H, Jain D, Tang DWT, Wong SH, et al · · 2024 · cited 53× · PMID 37935653 · DOI 10.5217/ir.2023.00080
2. Fecal transplantation for treatment of inflammatory bowel disease.
   Imdad A, Pandit NG, Zaman M, Minkoff NZ, et al · · 2023 · cited 51× · PMID 37094824 · DOI 10.1002/14651858.cd012774.pub3
3. Efficacy and safety of fecal microbiota transplantation <i>via</i> colonoscopy as add-on therapy in patients with mild-to-moderate ulcerative colitis: A randomized clinical trial.
   Tkach S, Dorofeyev A, Kuzenko I, Falalyeyeva T, et al · · 2022 · cited 10× · PMID 36714101 · DOI 10.3389/fmed.2022.1049849