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Investigation of the Optimal Cocktailed Probiotics for Decolonization of Vancomycin-resistant Enterococci in Human Gut

NCT03822819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-30

No results posted yet for this study

Summary

Vancomycin-resistant enterococci (VRE) has been a serious public health issue as an opportunistic pathogen and reservoir of antibiotic resistant genes. To reduce VRE carriage in human gut, investigators aim to look for effective probiotic cocktail to compete with VRE in human gut microflora via the technique of microbiome analysis pipeline (MAP). The probiotic cocktail gave by MAP result will be tested in a clinical trial, in which 80 subjects with VRE carriage will be enrolled and allocated randomly into two groups. Subjects in first group will be administered with probiotic cocktail capsules, and placebo capsules will be given to the second group in a double-blind manner. Stool samples will be collected from subjects before and after three weeks of probiotic/probiotic capsule uptake, and analyzed for VRE number and gut microflora changes to evaluate the efficacy of probiotic cocktail.

Conditions

  • Vancomycin-Resistant Enterococci
  • Probiotics

Interventions

DIETARY_SUPPLEMENT

probiotic cocktail capsules

Daily uptake of probiotic cocktail for three weeks

DIETARY_SUPPLEMENT

placebo capsules

Daily uptake of placebo capsule for three weeks

Sponsors & Collaborators

  • Taipei Medical University

    collaborator OTHER

  • Delta Electronics

    collaborator UNKNOWN

  • Taipei Medical University Shuang Ho Hospital

    lead OTHER

Principal Investigators

  • Shiuh-Bin Fang, M.D, Ph.D. · Taipei Medical University-ShuangHo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822819 on ClinicalTrials.gov