Comparison of Two Formulations of Bio-K

Antibiotic-Associated Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00792844
• Other study ID #: 1-Seto
• Status: Not yet recruiting
• Phase: N/A
• First received: November 17, 2008
• Last updated: November 17, 2008
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: November 2008
• Source: McMaster University
• Contact: Gloria Seto, BSchPhm
• Phone: 905-522-1155
• Email: gseto[@]stjosham.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic-Associated Diarrhea
• Diarrhea

Intervention

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 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

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton - Charlton Campus	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic-associated diarrhea		30 days after termination of antibiotic	No