Probiotic Efficacy in VRE Eradication

Not Applicable

Completed

• Conditions: VRE Colonization
• Interventions: Dietary Supplement: lactobacillus probiotic strain; Other: placebo

• Registration Number: NCT03560700
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-06
• Study Start: 2018-06-07
• Study First Posted: 2018-06-18
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactobacillus probiotic strain	lactobacillus probiotic strain	60 billion CFU/day
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with cleared VRE colonization at week 4	4 weeks	Fecal sample diagnosed by pcr and detection of the vanA gene

Secondary Outcome Measures

Name	Time	Method
Clearance of VRE colonization at week 8, 16 and 24 respectively	8, 16 and 24 weeks	Fecal sample diagnosed by pcr and detection of the vanA gene
Changes in fecal microbiota composition	24 weeks
Number of VRE infections (isolation from non-intestinal foci)	24 weeks
Colonization with probiotic lactobacillus strain	24 weeks

Trial Locations

Locations (1)

Hvidovre Hospital, Copenhagen University; 🇩🇰 Hvidovre, Copenhagen, Denmark