Probiotic Efficacy in VRE Eradication

NCT ID: NCT03560700

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-07
• Study Completion Date: 2021-11-01

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.

Conditions

VRE Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

lactobacillus probiotic strain

60 billion CFU/day

Group Type: EXPERIMENTAL

lactobacillus probiotic strain

Intervention Type: DIETARY_SUPPLEMENT

Approved Dietary supplement

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo comparator

Interventions

lactobacillus probiotic strain

Approved Dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo comparator

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chr Hansen

INDUSTRY

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andreas Munk Petersen

Md, Phd, Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hvidovre Hospital, Copenhagen University

Hvidovre, Copenhagen, Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 35475684 (View on PubMed)

Other Identifiers

H-18011991

Identifier Type: -

Identifier Source: org_study_id