Probiotic Efficacy in VRE Eradication

VRE Colonization Clinical Trial

— PROVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560700
• Other study ID #: H-18011991
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• VRE Colonization

Intervention

Dietary Supplement:
• lactobacillus probiotic strain
Approved Dietary supplement

Other:
• placebo
placebo comparator

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Copenhagen University	Hvidovre	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Chr Hansen

Country where clinical trial is conducted

Denmark, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with cleared VRE colonization at week 4	Fecal sample diagnosed by pcr and detection of the vanA gene	4 weeks
Secondary	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
Secondary	Number of VRE infections (isolation from non-intestinal foci)		24 weeks
Secondary	Changes in fecal microbiota composition		24 weeks
Secondary	Colonization with probiotic lactobacillus strain		24 weeks