NCT00958308

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_3

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

December 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 2, 2012

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

August 12, 2009

Results QC Date

February 1, 2012

Last Update Submit

March 9, 2012

Conditions

Antibiotic-Associated DiarrheaClostridium Difficile-Associated Diarrhea

Keywords

ProbioticAntibiotic-Associated Diarrhea (AAD) PreventionClostridium Difficile-Associated Diarrhea (CDAD)Prevention

Outcome Measures

Primary Outcomes (1)

  • To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.

    Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.

    Up to 40 days

Secondary Outcomes (4)

  • Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.

    Up to 40 days

  • Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.

    Up to 40 days

  • Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.

    Up to 40 days

  • Frequencies of Other Gastrointestinal Symptoms.

    Up to 40 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.

Other: Placebo

BIO-K+ CL-1285

ACTIVE COMPARATOR

Two probiotic capsules (BIO-K+ CL-1285®) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.

Other: BIO-K+ CL-1285®

BIO-K+ CL-1285® & placebo

OTHER

One probiotic capsule (BIO-K+ CL-1285®) and one placebo capsule (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.

Other: BIO-K+ CL-1285®Other: Placebo

Interventions

BIO-K+ CL-1285®OTHER

A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

BIO-K+ CL-1285BIO-K+ CL-1285® & placebo
PlaceboOTHER

Placebo is devoid of microorganisms.

BIO-K+ CL-1285® & placeboPlacebo

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Antibiotic therapy for a minimum of 3 days and a maximum of 14 days
  • Expected to remain hospitalized for a minimum of 5 days
  • Patients who have received less than 36 hours of antibiotic therapy
  • Negative pregnancy test at screening
  • Obtained his/her informed consent after verbal and written information
  • Patients having a telephone available (mobile, work, home)
  • Patients having a fridge at home

You may not qualify if:

  • Pregnant or breastfeeding women
  • Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).
  • Patients with a history of daily consumption of probiotics, fermented milk and/or yogurt;
  • Patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. Non-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal silicon dioxide)
  • Patients presenting with an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
  • A previous documented C. Difficile infection \< 3 months prior to study initiation ;
  • Ostomized patients, parenteral nutrition users
  • Patients with an immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, acquired immune deficiency syndrome (AIDS))
  • Ongoing or recent use of antibiotic therapy in the 30 days prior to the study product first administration.
  • Patients with planned administration of antibiotics other than broad spectrum Penicillin, Cephalosporin or Clindamycin for the treatment of an infection;
  • Patients with concomitant participation in another clinical trial;
  • Patients who are not likely to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9.

    PMID: 20145608RESULT

Related Links

Results Point of Contact

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

Study Officials

  • Gao XingWang, MD

    Xinhua/Yuyao Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

March 13, 2012

Results First Posted

March 2, 2012

Record last verified: 2012-03