Comparison of Two Formulations of Bio-K

Not Applicable

• Conditions: Antibiotic-Associated Diarrhea
• Interventions: Dietary Supplement: Bio-K capsule formulation; Dietary Supplement: Bio-K drink

• Registration Number: NCT00792844
• Lead Sponsor: McMaster University

Brief Summary

Main research Question: The investigators would like to find out if both the Bio-K (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective in the prevention of diarrhea associated with antibiotic use.

Why is this research project important? About 25% of patients who use antibiotics may develop diarrhea as a side effect. Symptoms are mild and consist of watery diarrhea and abdominal pain. Some patients may develop a more severe form of diarrhea, called clostridium difficile-associated diarrhea. Clostridium difficile-associated diarrhea may lead to more serious consequences like inflammation of the large bowel and in some cases, death. There are some studies that suggest Bio-K drink, a probiotic preparation containing lactobacillus acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. As a result, St. Joseph's Healthcare has recently to use Bio-K routinely to try to reduce risk of patients developing diarrhea. No other Hamilton hospitals use Bio-K routinely as there is not strong evidence about the effectiveness of Bio-K for the prevention of diarrhea. This study will provide more information about Bio-K's effectiveness in the prevention of diarrhea associated with antibiotic use as both a capsule and a drink.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-11
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Last Update Submitted: 2008-11-17
• Study First Posted: 2008-11-18
• Last Update Posted: 2008-11-18
• Study Start: 2009-02
• Primary Completion: 2009-05
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• speak English
• capable of providing consent
• reachable by telephone within the next three months
• willing to comply with study protocols
• age over 65 years
• prescribed clindamycin, fluoroquinolones or cephalosporin for more than one dose

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Exclusion Criteria

• ICU patients
• transplant patients
• patients on immunosuppressant medications (prednisone greater than 50 mg/day for 7 days, azathioprine, cyclosporine, cyclophosphamide, tacrolimus, sirolimus, methotrexate, mycophenolate, anti-TNF agents, interleukin-2 chemotherapy)
• HIV patients with CD4+ count less than 250 cells/mm3
• neutropenic patients with total neutrophil count less than 500
• patients with prosthetic heart valves

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio-K capsule	Bio-K capsule formulation	1 capsule of lactobacillus acidophilus and lactobacillus casei (50 billion live bacteria) daily for duration of antibiotic therapy and 7 days after or until discharge, whichever comes first
Bio-K liquid	Bio-K drink	98 g of lactobacillus acidophilus and lactobacillus casei (50 billion live bacteria) daily for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever comes first

Primary Outcome Measures

Name	Time	Method
Antibiotic-associated diarrhea	30 days after termination of antibiotic

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton - Charlton Campus; 🇨🇦 Hamilton, Ontario, Canada