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Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

Primary Purpose

Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BIO-K+ CL-1285®
Placebo
Sponsored by
Bio-K Plus International Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic-Associated Diarrhea focused on measuring Probiotic, Antibiotic-Associated Diarrhea (AAD) Prevention, Clostridium Difficile-Associated Diarrhea (CDAD)Prevention

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Other

    Arm Label

    Placebo

    BIO-K+ CL-1285

    BIO-K+ CL-1285® & placebo

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.
    Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.
    Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.
    If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.
    Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.
    Adverse events were reported by patients in the three study groups.
    Frequencies of Other Gastrointestinal Symptoms.
    Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.

    Full Information

    First Posted
    August 12, 2009
    Last Updated
    March 9, 2012
    Sponsor
    Bio-K Plus International Inc.
    Collaborators
    Sprim Advanced Life Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00958308
    Brief Title
    Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
    Official Title
    A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bio-K Plus International Inc.
    Collaborators
    Sprim Advanced Life Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea
    Keywords
    Probiotic, Antibiotic-Associated Diarrhea (AAD) Prevention, Clostridium Difficile-Associated Diarrhea (CDAD)Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    255 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    BIO-K+ CL-1285
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    BIO-K+ CL-1285® & placebo
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    BIO-K+ CL-1285®
    Intervention Description
    A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo is devoid of microorganisms.
    Primary Outcome Measure Information:
    Title
    To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.
    Description
    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.
    Time Frame
    Up to 40 days
    Secondary Outcome Measure Information:
    Title
    Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.
    Description
    Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.
    Time Frame
    Up to 40 days
    Title
    Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.
    Description
    If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.
    Time Frame
    Up to 40 days
    Title
    Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.
    Description
    Adverse events were reported by patients in the three study groups.
    Time Frame
    Up to 40 days
    Title
    Frequencies of Other Gastrointestinal Symptoms.
    Description
    Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.
    Time Frame
    Up to 40 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gao XingWang, MD
    Organizational Affiliation
    Xinhua/Yuyao Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20145608
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/20145608
    Description
    Dose-response probiotic study for AAD and CDAD

    Learn more about this trial

    Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

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