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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


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
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