Title: Efficacy of a Probiotic Fermented Drink of Lactobacillus Acidophilus and Lactobacillus Casei in the Reduction of Antibiotic-Associated Diarrhea
Abstract: Purpose: To assess the efficacy and safety of a commercially available probiotic drink comprised of 50 × 109 billion L. acidophilus and L. casei, Bio-K+ CL1285® (Bio-K+) in reducing Antibiotic-Associated Diarrhea (AAD) in patients on antibiotic regime who were initially treated in a hospital setting. Methods: This was a randomized, double blind, placebo controlled trial. Adults patients who were prescribed antibiotics for 3 –14 days were enrolled from eight Canadian centers. Study treatment was randomized at a 1:1 ratio of Bio-K+ or placebo and was administered within 24 hours of initiation to 5 days after termination of antibiotic therapy. Patients were followed for 21 days after the last dose of study treatment. The primary efficacy outcome measure was the occurrence and frequency of new onset AAD. The secondary outcome measure was the incidence of Clostridium Difficile-Associated Diarrhea (CDAD). Results: Among the 472 patients eligible for randomization there were 29 excluded because antibiotic treatment duration was less than 3 days and 6 because diarrhea onset was before initiation of study treatment. The ITT analysis was based on 437 (93%) of the eligible and enrolled patients in the study. The mean age of the patients in the study was approximately 60 years and 50% were male. The mean duration of antibiotic treatment was approximately 9 days and the mean duration of study treatment was approximately 12 days for both study groups. The mean (SD) number of diarrhea episodes was 1.19. (3.20) for the placebo and 0.67 (2.05) for Bio-K+ (P= 0.040). Multivariate linear regression results adjusting for duration of study treatment, duration of antibiotic therapy and patient's age showed that the duration of diarrhea for Bio-K+ versus placebo was reduced by 51.5% (b (SE) = 0.515 (0.256); P= 0.045). Multivariate logistic regression results showed that the adjusted odds ratio of diarrhea for Bio-K+ versus placebo was 0.627 (P= 0.037). The odd rations for diarrhea duration ≥ 2 and ≥ 3 days were 0.531 (P= 0.025) and 0.488 (P= 0.034) respectively. Four patients in the placebo group and one in the Bio-K+ group developed CDAD (P= 0.372). Study treatment was well tolerated and with similar low incidence of mild non serious adverse events similar in both groups. Conclusion: Probiotic prophylaxis of a commercially available fermented drink composed of 50 × 109 billion L. acidophilus and L. casei (Bio-K+ CL1285®) is well tolerated and effective in the reduction of the incidence and duration of AAD for patients receiving antibiotics that were initially treated in a hospital setting.
Publication Year: 2008
Publication Date: 2008-09-01
Language: en
Type: article
Indexed In: ['crossref']
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