Comparison of Two Formulations of Bio-K

McMaster University

Status: Unknown

Conditions: Antibiotic-Associated Diarrhea

Treatments: Dietary Supplement: Bio-K drink; Dietary Supplement: Bio-K capsule formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00792844

1-Seto

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Bio-K capsule

Experimental group

Description:

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

Treatment:

Dietary Supplement: Bio-K capsule formulation

Bio-K liquid

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Bio-K drink

no Bio-K

No Intervention group

Description:

No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)