Study Title and Description
Prevention of beta-lactam-associated diarrhea by Saccharomyces boulardii compared with placebo.
Key Questions Addressed
|9||Key Question 9 - Probiotic or prebiotic interventions for prevention of initial and recurrent CDI|
Primary Publication Information
|Title||Prevention of beta-lactam-associated diarrhea by Saccharomyces boulardii compared with placebo.|
|Author||McFarland LV., Surawicz CM., Greenberg RN., Elmer GW., Moyer KA., Melcher SA., Bowen KE., Cox JL.|
|Country||Department of Medicinal Chemistry, University of Washington, Seattle.|
Pubmed ID: 7872284
Secondary Publication Information
There are currently no secondary publications defined for this study.
Extraction Form: Key Question 4 - Probiotic or prebiotic interventions for prevention of initial and recurrent CDI (Table 20)
|Question... Follow Up||Answer||Follow-up Answer|
|Country / Study Design||United States Randomized controlled trial|
|Sample||193 hospitalized adult patients receiving new beta- lactam antibiotic with or without another antibiotic and no diarrhea 129 (67%) completed study Mean age: 42 years Gender: Male 65%|
|Prevention of initial or recurrent Clostridium difficile infection?||Primary Prevention of Initial Clostridium difficile infection|
|Intervention/Comparison and Method||Probiotic: Lyophilized S. boulardii 3x1010 cfu (1 g) orally in two 250 mg capsules/d within 72 hours of antibiotic and until max of 28 days (n=97) Placebo 1 g (undefined) (n=96) Followup for 7 days after stopping drug|
|C. difficile Diarrhea (Diarrhea and CD Toxin +)||Overall incidence of AAD: Probiotic: 3/97 (3.1%) Placebo: 4/96 (4.2%) Fisher’s Exact test performed by reviewers p=0.72 Development of ADD in 24 patients with positive CD assays: Probiotic: 3/10 (30%) Placebo: 4/14 (29%) (The power of detecting a significant difference based on the sample size of 24 and the above rates was less than 3%)|
|Later Recurrence of CD Diarrhea|
|Notes of Study Quality and Side Effects||Allocation concealment: adequate (appearance and odor of the capsules of interventions were identical, done centrally Blinding: double Intention-to-treat analysis: yes Withdrawals and dropouts adequately described: yes Notes: 3 reviewers of diarrhea|
Results & Comparisons
No Results found.