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

This study has been completed.
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Bio-K Plus International Inc.
ClinicalTrials.gov Identifier:
NCT00958308
First received: August 12, 2009
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Antibiotic-Associated Diarrhea
Clostridium Difficile-Associated Diarrhea
Other: BIO-K+ CL-1285®
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:
  • To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: Up to 40 days ] [ Designated as safety issue: Yes ]
    Adverse events were reported by patients in the three study groups.

  • Frequencies of Other Gastrointestinal Symptoms. [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
    Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.


Enrollment: 255
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958308

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

Additional Information:
Publications:
Responsible Party: Bio-K Plus International Inc.
ClinicalTrials.gov Identifier: NCT00958308     History of Changes
Other Study ID Numbers: 07-SC-9-BIK-01, CL 1285-AAD-CH01
Study First Received: August 12, 2009
Results First Received: February 1, 2012
Last Updated: March 9, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Bio-K Plus International Inc.:
Probiotic
Antibiotic-Associated Diarrhea (AAD) Prevention
Clostridium Difficile-Associated Diarrhea (CDAD)Prevention

Additional relevant MeSH terms:
Cross Infection
Diarrhea
Infection
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014