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

Faecal Microbiota Transplantation Clinical Trial

— FEMRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742074
• Other study ID #: H-22040517
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2023
• Est. completion date: November 30, 2028

Study information

• Verified date: October 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Faecal Microbiota Transplantation
• Multidrug Resistant Organisms

Intervention

Other:
• Faecal microbiota transplantation
25-30 capsules of faecal material
• Placebo
25-30 placebo capsules

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Copenhagen University	Hvidovre	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Aarhus University Hospital, Odense University Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of participants with adverse events.	Number of participants with adverse events both severe and non-severe.	8 weeks, 16 weeks and 6 months.
Secondary	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
Secondary	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
Secondary	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