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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

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ClinicalTrials.gov Identifier: NCT00958308
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : March 2, 2012
Last Update Posted : March 13, 2012
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Bio-K Plus International Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Antibiotic-Associated Diarrhea Clostridium Difficile-Associated Diarrhea Other: BIO-K+ CL-1285® Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : December 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea
Drug Information available for: Chlorine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
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
Placebo is devoid of microorganisms.
Active Comparator: BIO-K+ CL-1285
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®
A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
BIO-K+ CL-1285® & placebo
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®
A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.

Other: Placebo
Placebo is devoid of microorganisms.


Outcome Measures
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Primary Outcome Measures :
  1. To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. [ Time Frame: Up to 40 days ]
    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 :
  1. Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo. [ Time Frame: Up to 40 days ]
    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.

  2. Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B. [ Time Frame: Up to 40 days ]
    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.

  3. Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients. [ Time Frame: Up to 40 days ]
    Adverse events were reported by patients in the three study groups.

  4. Frequencies of Other Gastrointestinal Symptoms. [ Time Frame: Up to 40 days ]
    Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958308


Sponsors and Collaborators
Bio-K Plus International Inc.
Sprim Advanced Life Sciences
Investigators
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Principal Investigator: Gao XingWang, MD Xinhua/Yuyao Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Bio-K Plus International Inc.
ClinicalTrials.gov Identifier: NCT00958308    
Other Study ID Numbers: 07-SC-9-BIK-01
CL 1285-AAD-CH01
First Posted: August 13, 2009    Key Record Dates
Results First Posted: March 2, 2012
Last Update Posted: March 13, 2012
Last Verified: March 2012
Keywords provided by Bio-K Plus International Inc.:
Probiotic
Antibiotic-Associated Diarrhea (AAD) Prevention
Clostridium Difficile-Associated Diarrhea (CDAD)Prevention
Additional relevant MeSH terms:
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Clostridium Infections
Cross Infection
Diarrhea
Infections
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Iatrogenic Disease
Disease Attributes
Pathologic Processes