NCT03822819

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

January 28, 2019

Last Update Submit

March 26, 2020

Conditions

Vancomycin-Resistant EnterococciProbiotics

Keywords

vancomycin-resistant entercocciprobioticsmicrobiome analysis pipelinenext generation sequencingdecolonizationvirulence gene

Outcome Measures

Primary Outcomes (1)

  • VRE number change

    Stool samples will be collected from participants before and after capsule uptake and plating out on selective medium for VRE after proper serial dilution. VRE number is defined as VRE CFU per gram of stool sample, and compared between two samples from the same participant.

    after 30 days of capsules uptake

Study Arms (2)

probiotic cocktail capsules uptake

EXPERIMENTAL

Participants take two capsules of probiotic cocktail everyday for 30 days in a double-blinded masking. Stool samples will be collected before and after capsule uptake and be analyzed for VRE number and microbiota change.

Dietary Supplement: probiotic cocktail capsules

placebo capsules uptake

PLACEBO COMPARATOR

Participants take two capsules of placebo everyday for 30 days in a double-blinded masking. Stool samples will be collected before and after capsule uptake and be analyzed for VRE number and microbiota change.

Dietary Supplement: placebo capsules

Interventions

probiotic cocktail capsulesDIETARY_SUPPLEMENT

Daily uptake of probiotic cocktail for three weeks

probiotic cocktail capsules uptake
placebo capsulesDIETARY_SUPPLEMENT

Daily uptake of placebo capsule for three weeks

placebo capsules uptake

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • VRE-carriage
  • of age between 20 and 90-year-old
  • agreeing to participate

You may not qualify if:

  • routine probiotic uptake in daily life, or being prescribed with probiotics in clinic one- week before or in the period of clinical trial
  • being prescribed with oral antibiotic uptake in the period of clinical trial
  • with diarrhea symptom
  • in pregnancy
  • of immuno-compromised conditions or being prescribed with steroid-type medicines
  • with diabetes mellitus
  • critically ill patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Study Officials

  • Shiuh-Bin Fang, M.D, Ph.D.

    Taipei Medical University-ShuangHo Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiuh-Bin Fang, M.D, Ph.D.

CONTACT

+886 2 22490088sbfang@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is going to be carried out with two groups in which participants are either administered with probiotic cocktail capsules or placebo capsules
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

March 15, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

TW(1)