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Comparison of Two Formulations of Bio-K

NCT00792844 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2008-11-18

No results posted yet for this study

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.

Conditions

  • Antibiotic-Associated Diarrhea

Interventions

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00792844 on ClinicalTrials.gov