NCT05461833

FMT for Post-infectious IBS

Fecal Microbiota Transplantation in Patients With Post-infection Irritable Bowel Syndrome: a Randomized, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Bogomolets National Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Research in recent years has also shown the potential benefits of fecal microbiota transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota with fecal material from a healthy donor. Even though the only officially approved indication for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT is nevertheless being studied for the treatment of other gastrointestinal and non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT for IBS, and most of them have demonstrated positive results. The investigators have not come across studies devoted to the study of the effectiveness of FMT in patients with PI-IBS in the available literature. So, the aim of the current study was to conduct single-centre, randomized clinical trial to assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Fecal transplantation	Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.
DRUG	OTILONII BROMIDUM	OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment
DIETARY_SUPPLEMENT	multi-strain probiotic	multi-strain probiotic, oral, 1 capsule BID for 1 month

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-31
• Completion: 2022-01-15
• First posted: 2022-07-18
• Last updated: 2022-07-18

Locations

2 sites across 1 country: Ukraine