Clinical trial NCT03560700: Probiotic Efficacy in VRE Eradication
Official title: The Effect of a Lactobacillus Probiotic Strain on Eradication of Vancomycin Resistant Enterococcus Faecium (VRE) in Non-symptomatic VRE-carriers - a Multicenter, Randomized, Placebo-controlled, Parallel-group Study With 4 Weeks Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: VRE Colonization
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Chr Hansen
First posted: 2018-06-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the efficacy of a probiotic lactobacillus strain in eradicating VRE in non-symptomatic carriers after 4 weeks of treatment. It will also evaluate the long-term efficacy after 8,16 and 24 weeks.

Detailed description: With the increased number of Vancomycin-Resistant Enterococcus faecium (VRE) infected/colonized people it is evident that new treatment options are needed to reduce the number of VRE cases. One such option could be to use probiotics. We hypothesize that treatment with a probiotic lactobacillus strain can reduce the number of VRE carriers significantly. The aim is to investigate if this strain can eradicate VRE in non-symptomatic VRE-carriers measured as the number of subjects without VRE colonization at week 4.

This is a multi-center, randomized, double-blind, placebo-controlled parallel-group trial in non-symptomatic VRE-carriers.

The Trial consists of a 4 weeks intervention period followed by a 20-week follow-up period.

After patients have been confirmed as carriers of VRE, the subjects are randomized to 4 weeks' treatment with a lactobacillus probiotic strain (60 billion CFU per day) or to placebo. Subjects' VRE carrier-state is assessed at weeks 4, 8, 16 and 24, by an in-house PCR analysis. Stool samples are collected before intervention (baseline) and at week 4, 8, 16 and week 24.

Eligibility criteria: Inclusion Criteria:

* Subjects with VRE colonization (positive faecal swab)
* Subjects over 18 years of age
* Provided voluntary written informed consent

Exclusion Criteria:

* Symptomatic VRE infection
* Serious immunodeficiency
* Pancreatitis
* Planned or recent intraabdominal operation within a time window of14 days)
* Parenteral nutrition
* Antibiotic treatment for VRE one month prior to inclusion
* Terminal disease with expected survival time \< 3 month
* Probiotic consumption within two weeks prior enrollment
* Pregnant

Primary outcomes:
measure: Number of subjects with cleared VRE colonization at week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Clearance of VRE colonization at week 8, 16 and 24 respectively
timeFrame: 8, 16 and 24 weeks
measure: Number of VRE infections (isolation from non-intestinal foci)
timeFrame: 24 weeks
measure: Changes in fecal microbiota composition
timeFrame: 24 weeks
measure: Colonization with probiotic lactobacillus strain
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Copenhagen University
state: Copenhagen
Study officials:
References:
citation: Rubin IMC, Mollerup S, Broholm C, Knudsen SB, Baker A, Helms M, Holm MKA, Kallemose T, Westh H, Dahl Knudsen J, Pinholt M, Petersen AM. No Effect of Lactobacillus rhamnosus GG on Eradication of Colonization by Vancomycin-Resistant Enterococcus faecium or Microbiome Diversity in Hospitalized Adult Patients. Microbiol Spectr. 2022 Jun 29;10(3):e0234821. doi: 10.1128/spectrum.02348-21. Epub 2022 Apr 27.