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

NCT05742074 | Completed

• 1 other identifier: H-22040517
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multidrug Resistant Organisms; Faecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of participants with MRO clearance

  16 weeks

• Number of participants with adverse events.

  8 weeks, 16 weeks and 6 months.

• Comparison of the frequency of invasive infections

  6 months

• 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.

  8 weeks and 16 weeks

Study Arms (2)

FMT (faecal microbiota transplantation)

EXPERIMENTAL

25-30 capsules of faecal material.

Other: Faecal microbiota transplantation

Placebo

PLACEBO COMPARATOR

25-30 placebo capsules.

Other: Placebo

Interventions

Faecal microbiota transplantation OTHER

25-30 capsules of faecal material

FMT (faecal microbiota transplantation)

Placebo OTHER

25-30 placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Zealand University Hospital: collaborator

Study Sites (1)

Hvidovre Hospital, Copenhagen University

Hvidovre, Copenhagen, 2650, Denmark

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 23, 2023
• Study Start: March 24, 2023
• Primary Completion: February 11, 2025
• Study Completion: December 5, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

DK (1)