NCT00328263

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
472

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

8 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

May 17, 2006

Results QC Date

August 28, 2012

Last Update Submit

July 15, 2014

Conditions

DiarrheaClostridium Infections

Keywords

Bio-K+CL1285ProbioticsAntibiotics-associated diarrheaClostridium difficile-associated diarrheaLactobacillus acidophilusClostridium Difficile

Outcome Measures

Primary Outcomes (1)

  • The Incidence of Antibiotic-associated Diarrhea.

    Presence of at least one diarrhea episode within 24 hours.

    Up to 40 days

Secondary Outcomes (3)

  • Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.

    Up to 40 days

  • Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

    Up to 40 days

  • Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics

    Up to 40 days

Study Arms (2)

1

EXPERIMENTAL

Bio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria.

Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei

2

PLACEBO COMPARATOR

placebo devoid of bacteria

Dietary Supplement: placebo

Interventions

Lactobacillus acidophilus CL1285 and Lactobacillus caseiDIETARY_SUPPLEMENT

One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

Also known as: BioK CL1285
1
placeboDIETARY_SUPPLEMENT

One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.

2

Eligibility Criteria

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

You may qualify if:

  • presenting to the Emergency Room and considered for admission to hospital for a minimum of 12 hours and requiring antibiotic administration for the treatment of a suspected or proven bacterial infection OR a hospitalized patient developing a suspected or proven nosocomial infection OR an external patient that come to the hospital for repeated visits to receive his intravenous antibiotic therapy for the treatment of a suspected or proven bacterial infection. The external patients on oral antibiotics that come to the hospital for repeated visits to receive any other treatments requiring a hospital stay of more than one hour will also be included.
  • Hospital employee on antibiotics can also be included in the study
  • having received less than 24 hours of antibiotic therapy;
  • requiring a minimum of 3 days and a maximum of 14 days antibiotic administration
  • Informed consent must be obtained in writing for all subjects at enrollment into the study

You may not qualify if:

  • Subjects presenting with any of the following will not be included in the study:
  • active diarrhea;
  • a history of daily consumption of fermented milk and/or yogurt;
  • intolerance to lactose;
  • pregnant/breastfeeding women;
  • an active, non controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
  • ileostomy, jejunostomy or colostomy;
  • immunosuppressed state;
  • a previous documented C. difficile infection in the three months prior to study initiation;
  • active radiotherapy or chemotherapy;
  • recent (\< 6 months) or planned bone marrow graft or organ transplant;
  • antibiotic therapy in the fourteen days prior to study initiation;
  • the planned administration of metronidazole (alone or in combination) or vancomycin monotherapy for the treatment of an infection;
  • mental or other conditions, or language barriers rendering the subject unable to understand the nature, scope, and possible consequences of the study or complete the self-administered questionnaires;
  • subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hamilton General Hospital

Hamilton, Ontario, L8L-2X2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Hotel Dieu de Chicoutimi

Chicoutimi, Quebec, G7H5H6, Canada

Location

St-Mary Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

Hotel-Dieu de St-Jerome

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Centre Hospitalier Régional de Trois-Rivières

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

MeSH Terms

Conditions

DiarrheaClostridium Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Dr. Serge Carrière
Organization
Bio-K+ International Inc.
scarriere@biokplus.com
450-978-2465

Study Officials

  • Joe S Dylewski, MD

    St-Mary Hospital Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 19, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2007

Study Completion

October 1, 2007

Last Updated

August 7, 2014

Results First Posted

August 7, 2014

Record last verified: 2014-07

Locations

CA(8)