Comparison of Two Formulations of Bio-K

Study Overview
=================
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.

Official Title
-----------------
Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study

Conditions
-----------------
Antibiotic-Associated Diarrhea

Intervention / Treatment
-----------------
* Dietary Supplement: Bio-K capsule formulation
* Dietary Supplement: Bio-K drink


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bio-K capsule<br>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 | Dietary Supplement: Bio-K capsule formulation<br>* Bio-K 1 capsule formulation daily for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first<br>|
| Active Comparator: Bio-K liquid<br>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 | Dietary Supplement: Bio-K drink<br>* Bio-K 98 g of diary-free soy beverage formulation for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first<br>|
| No Intervention: no Bio-K<br>No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic-associated diarrhea |  | 30 days after termination of antibiotic |