Antibiotic-Associated Diarrhea
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBio-K capsule formulation
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
DIETARY_SUPPLEMENTBio-K drink
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
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibiotic-associated diarrhea | 30 days after termination of antibiotic |
Countries
Canada
Contacts
Primary ContactGloria Seto, BSchPhm
Outcome results
None listed