NCT05742074

The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers

The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers - a Multicentre, Randomized, Double-blinded and Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO e.g. Vancomycin resistant Enterococcus Faecium (VRE), carbapenemase-producing Enterobacterales (CPE) and extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E).

Detailed description

The study is designed as a randomized, double-blinded and placebo-controlled clinical trial. The participants (n = 80) will be randomized 1:1 to FMT or placebo. FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days, if one day is unacceptable to the participant. At baseline, eight weeks, and 16 weeks rectal swabs for PCR and culture will be taken. Regarding VRE and CPO, there are specific PCRs followed by confirmatory culture, whereas ESBL-E is detected by culture of rectal swab. Furthermore, participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome.

Conditions

• Multidrug Resistant Organisms
• Faecal Microbiota Transplantation

Interventions

Type	Name	Description
OTHER	Faecal microbiota transplantation	25-30 capsules of faecal material
OTHER	Placebo	25-30 placebo capsules

Timeline

• Start date: 2023-03-24
• Primary completion: 2025-02-11
• Completion: 2025-12-05
• First posted: 2023-02-23
• Last updated: 2026-04-17

Locations

1 site across 1 country: Denmark