NCT00941356

Brief Summary

Trial Objectives: Primary objective:

  • To evaluate the efficacy of Bio-K+CL1285® in patients with Methicillin-Resistant S. aureus (MRSA) nasal colonization by comparing the MRSA decolonization following either Bio-K+CL1285® or placebo treatment. Secondary objective:
  • To evaluate the safety profile of Bio-K+CL1285®.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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 15, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

6.5 years

First QC Date

January 15, 2009

Last Update Submit

July 21, 2022

Conditions

MRSA Colonization

Keywords

MRSA nasal colonisationProbiotics

Outcome Measures

Primary Outcomes (1)

  • Frequency of subjects with MRSA decolonization

    21 days

Secondary Outcomes (1)

  • To evaluate the secondary effects (incidence rate of non-serious ans serious adverse events)associated to the administration of the study product

    21 days

Study Arms (2)

1

EXPERIMENTAL

Bio-K+ CL1285 contains 50 billion of live bacteria

Dietary Supplement: Bio-K+ CL1285

2

PLACEBO COMPARATOR

placebo devoid of bacteria

Dietary Supplement: Placebo

Interventions

Bio-K+ CL1285DIETARY_SUPPLEMENT

2 capsules per day before breakfast

Also known as: Bio-K+ CL1285(R) Extra Strength
1
PlaceboDIETARY_SUPPLEMENT

2 capsules per day before breakfast

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients having ≥18 years of age
  • Women of child bearing capacity who are not pregnant at the moment of screening (Pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. condom, oral contraceptives, etc.) are allowed to participate.
  • Patients must have nasal MRSA colonization confirmed with MRSA positive culture as assessed during the screening visit without any clinical signs or symptoms of infection.
  • Laboratory test results within the normal ranges.
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Patients treated for nasal MRSA decolonization in the last 6 months;
  • Current infection with MRSA;
  • Ongoing or active infection;
  • Daily probiotic/ fermented milk or Yogurt use;
  • Known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study agent (capsules);
  • Ongoing or recent use of antibiotics in the 30 days prior to the study agent administration;
  • Pregnancy, breastfeeding;
  • Regular use of nasal agents;
  • Uncontrolled intercurrent illness, including situations that would limit compliance with study requirements;
  • Patients with open wounds
  • Immunosuppressive therapy or any health condition causing inmunosuppression (Including Haematological malignancies, AIDS);
  • Ostomized patients, parenteral nutrition users;
  • Patients with current vascular access (catheter) or planned to have installed a vascular access (catheter) or any prosthesis during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pierre Le Gardeur Hospital

Terrebonne, Quebec, J6V 2H2, Canada

Location

Study Officials

  • Dr Pierre-Jean PM Maziade, MD

    Pierre Le Gardeur Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

July 17, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations

CA(1)