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

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

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).

Study Overview

• Status: Completed
• Conditions: Faecal Microbiota Transplantation; Multidrug Resistant Organisms
• Intervention / Treatment: Other: Faecal microbiota transplantation; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Hvidovre Hospital, Copenhagen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: minimum 18 years
• Positive rectal PCR and/or culture for MRO
• Ability to speak and understand Danish or English
• Capable of swallowing the capsules

Exclusion Criteria:

• Current invasive infection with an MRO e.g. in abdomen, bloodstream or symptomatic urinary tract infection.
• Severe immune deficiency (defined as current chemo treatment or neurofilocytes < 1000/mm3
• Pancreatitis, defined by pancreatic amylases above the upper reference limit
• Planned or recent abdominal surgery (within 14 days)
• Parenteral nutrition
• Current antibiotic treatment of the same MRO as intestinal carriage
• Terminal disease with expected survival under three months
• Sepsis defined according to Surviving Sepsis Campaign guidelines
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT (faecal microbiota transplantation); 25-30 capsules of faecal material.	Other: Faecal microbiota transplantation; 25-30 capsules of faecal material
Placebo Comparator: Placebo; 25-30 placebo capsules.	Other: Placebo; 25-30 placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with MRO clearance	Number of participants with MRO clearance after eight weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The results from the test will be positive or negative.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with MRO clearance	Number of participants with negative PCR for MRO on rectal swab and faecal culture negative for MRO after 16 weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The result from the test will be positive or negative	16 weeks
Number of participants with adverse events.	Number of participants with adverse events both severe and non-severe.	8 weeks, 16 weeks and 6 months.
Comparison of the frequency of invasive infections	Comparison of the frequency of invasive infections with the same MRO as the intestinal carriage between the FMT and the placebo group.	6 months
Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.	Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.	6 months
Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.	Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.	8 weeks and 16 weeks

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Odense University Hospital; Zealand University Hospital; Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): December 5, 2025

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: H-22040517

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No