Probiotic Efficacy in VRE Eradication (PROVE)

Hvidovre University Hospital

Status: Completed

Conditions: VRE Colonization

Treatments: Other: placebo; Dietary Supplement: lactobacillus probiotic strain

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03560700

H-18011991

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

lactobacillus probiotic strain

Experimental group

Description:

60 billion CFU/day

Treatment:

Dietary Supplement: lactobacillus probiotic strain

placebo

Placebo Comparator group

Treatment:

Other: placebo