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

Antibiotic-Associated Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958308
• Other study ID #: 07-SC-9-BIK-01
• Secondary ID: CL 1285-AAD-CH01
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2009
• Last updated: March 9, 2012
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: March 2012
• Source: Bio-K Plus International Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic-Associated Diarrhea
• Clostridium Difficile-Associated Diarrhea
• Cross Infection
• Diarrhea

Intervention

Other:
• BIO-K+ CL-1285®
A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.
• Placebo
Placebo is devoid of microorganisms.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bio-K Plus International Inc.	Sprim Advanced Life Sciences

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Up to 40 days	No
Secondary	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.	Up to 40 days	No
Secondary	Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.	Adverse events were reported by patients in the three study groups.	Up to 40 days	Yes
Secondary	Frequencies of Other Gastrointestinal Symptoms.	Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.	Up to 40 days	No

External Links

•   Dose-response probiotic study for AAD and CDAD