Probiotic Efficacy in VRE Eradication | NCT03560700

Studies
Probiotic Efficacy in VRE Eradication

NCT03560700

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Oct 3, 2023Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

VRE Colonization

Interventions

lactobacillus probiotic strain
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2018Actual

Primary Completion Date

Nov 1, 2021Actual

Completion Date

Nov 1, 2021Actual

First Submitted Date

May 24, 2018

First Submission Date that Met QC Criteria

Jun 6, 2018

First Posted Date

Jun 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2023

Last Update Posted Date

Oct 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Munk Petersen, Md, Phd, Consultant, Hvidovre University HospitalPrincipal Investigator

Lead Sponsor

Hvidovre University HospitalOTHER

Collaborators

Name	Class
Chr Hansen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lactobacillus probiotic strain	Experimental	60 billion CFU/day	Dietary Supplement: lactobacillus probiotic strain
placebo	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lactobacillus probiotic strain	Dietary Supplement	Approved Dietary supplement	lactobacillus probiotic strain

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital, Copenhagen University		Hvidovre	Copenhagen	2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35475684	Result	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.