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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
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Primary Publication Information
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TitleData
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.
Year 1995
Numbers Pubmed ID: 7872284
1457 (internal)

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)
Design Details
Question... Follow Up Answer Follow-up Answer
Country / Study Design United States Randomized controlled trial
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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%
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Prevention of initial or recurrent Clostridium difficile infection? Primary Prevention of Initial Clostridium difficile infection
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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
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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%)
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Later Recurrence of CD Diarrhea
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CD Toxin+
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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
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Results & Comparisons

No Results found.