Probiotic Efficacy in VRE Eradication
PROVE
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
1 other identifier
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedStudy Start
First participant enrolled
June 7, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedOctober 3, 2023
September 1, 2023
3.4 years
May 24, 2018
September 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with cleared VRE colonization at week 4
Fecal sample diagnosed by pcr and detection of the vanA gene
4 weeks
Secondary Outcomes (4)
Clearance of VRE colonization at week 8, 16 and 24 respectively
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
Study Arms (2)
lactobacillus probiotic strain
EXPERIMENTAL60 billion CFU/day
placebo
PLACEBO COMPARATORInterventions
Approved Dietary supplement
Eligibility Criteria
You may qualify if:
- Subjects with VRE colonization (positive faecal swab)
- Subjects over 18 years of age
- Provided voluntary written informed consent
You may not qualify if:
- Symptomatic VRE infection
- Serious immunodeficiency
- Pancreatitis
- Planned or recent intraabdominal operation within a time window of14 days)
- Parenteral nutrition
- Terminal disease with expected survival time \< 3 month
- Probiotic consumption within two weeks prior enrollment
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- Chr Hansencollaborator
Study Sites (1)
Hvidovre Hospital, Copenhagen University
Hvidovre, Copenhagen, 2650, Denmark
Related Publications (1)
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.
PMID: 35475684RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Md, Phd, Consultant
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 18, 2018
Study Start
June 7, 2018
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
October 3, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share