NCT03822819

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

Status unknown NA Last updated 30 March 2020

What this trial tests

NA trial testing probiotic cocktail capsules in Vancomycin-Resistant Enterococci in 100 participants. Status unknown.

Timeline

15 March 2019

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	Taipei Medical University Shuang Ho Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	15 March 2019
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• probiotic cocktail capsules
• placebo capsules — full drug profile →

Conditions studied

• Vancomycin-Resistant Enterococci — all drugs for Vancomycin-Resistant Enterococci →
• Probiotics — all drugs for Probiotics →

Sponsor

Taipei Medical University Shuang Ho Hospital

Who can join

Adults 20 to 90, any sex, with Vancomycin-Resistant Enterococci or Probiotics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Probiotics, Prebiotics and Synbiotics in Combating Multidrug-Resistant Organisms.
   Newman AM, Arshad M. · · 2020 · cited 40× · PMID 32800382 · DOI 10.1016/j.clinthera.2020.06.011
2. Probiotics and Their Bioproducts: A Promising Approach for Targeting Methicillin-Resistant <i>Staphylococcus aureus</i> and Vancomycin-Resistant <i>Enterococcus</i>.
   Jain M, Stitt G, Son L, Enioutina EY. · · 2023 · cited 17× · PMID 37894051 · DOI 10.3390/microorganisms11102393
3. Bacterial, Gut Microbiome-Modifying Therapies to Defend against Multidrug Resistant Organisms.
   Feehan A, Garcia-Diaz J. · · 2020 · cited 14× · PMID 31991615 · DOI 10.3390/microorganisms8020166
4. Probiotic Cocktail Identified by Microbial Network Analysis Inhibits Growth, Virulence Gene Expression, and Host Cell Colonization of Vancomycin-Resistant Enterococci.
   Sun WS, Lee YJ, Tsai KN, Ho YH, et al · · 2020 · cited 6× · PMID 32486106 · DOI 10.3390/microorganisms8060816