NCT04899869

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Faecal Microbiota Transplantation in Irritable Bowel Syndrome: a Randomised, Double-blind Cross-over Study Utilising Mixed Microbiota From Healthy Donors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Thomayer University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.

Detailed description

Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will undergo two pairs of faecal microbiota transplantation (a total of four enemas for each patient), with the pairs of transfers being eight weeks apart. The active intervention substance is a mixed stool microbiota derived from healthy individuals, screened for infectious diseases according to European consensus conference on faecal microbiota transplantation guidelines, and who were preselected for high alpha diversity of their microbiome and distance in community ordination from IBS patients microbiota. Placebo is the same mixture, inactivated by autoclaving.

Conditions

• Irritable Bowel Syndrome With Diarrhea
• Irritable Bowel Syndrome Mixed

Interventions

Type	Name	Description
OTHER	Faecal microbiota transplantation with active study microbiota first	2x enema with active study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
OTHER	Faecal microbiota transplantation with inactive autoclaved study microbiota first	2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with active study microbiota
OTHER	Faecal microbiota transplantation with inactive autoclaved study microbiota only	2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota

Timeline

• Start date: 2021-06-17
• Primary completion: 2024-03-27
• Completion: 2024-04-29
• First posted: 2021-05-25
• Last updated: 2024-05-24

Locations

1 site across 1 country: Czechia