Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
McMaster University |
---|---|
Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00792844 |
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.
Condition | Intervention |
---|---|
Antibiotic-Associated Diarrhea |
Dietary Supplement: Bio-K capsule formulation Dietary Supplement: Bio-K drink |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Bio-equivalence Study |
Official Title: | Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study |
Estimated Enrollment: | 90 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Bio-K capsule: Experimental
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
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
|
Bio-K liquid: Active Comparator
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
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
|
no Bio-K: No Intervention
No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)
|
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gloria Seto, BSchPhm | 905-522-1155 ext 33803 | gseto@stjosham.on.ca |
Canada, Ontario | |
St. Joseph's Healthcare Hamilton - Charlton Campus | |
Hamilton, Ontario, Canada, L8N 4A6 |
Responsible Party: | St. Joseph's Healthcare Hamilton ( Gloria Seto ) |
Study ID Numbers: | 1-Seto |
Study First Received: | November 17, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00792844 |
Health Authority: | Canada: Ethics Review Committee |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive |