Probiotic Efficacy in VRE Eradication

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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VRE Colonization

Intervention / Treatment
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* Dietary Supplement: lactobacillus probiotic strain
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lactobacillus probiotic strain<br>60 billion CFU/day | Dietary Supplement: lactobacillus probiotic strain<br>* Approved Dietary supplement<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with cleared VRE colonization at week 4 | Fecal sample diagnosed by pcr and detection of the vanA gene | 4 weeks | 

Secondary Outcome Measures

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