VRE Colonization
Conditions
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.
Interventions
DIETARY_SUPPLEMENTlactobacillus probiotic strain
Approved Dietary supplement
OTHERplacebo
placebo comparator
Sponsors
Chr Hansen
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with cleared VRE colonization at week 4 | 4 weeks | Fecal sample diagnosed by pcr and detection of the vanA gene |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Countries
Denmark
Outcome results
None listed