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Study Title and Description

Prevention of antibiotic-associated diarrhea by Saccharomyces boulardii: a prospective study.



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 antibiotic-associated diarrhea by Saccharomyces boulardii: a prospective study.
Author Surawicz CM., Elmer GW., Speelman P., McFarland LV., Chinn J., van Belle G.
Country Department of Medicine, University of Washington, Seattle.
Year 1989
Numbers Pubmed ID: 2494098
1456 (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 318 hospitalized patients given new antibiotics 180 completed study, 138 had C. difficile tested Mean age: 46.5 years Gender: Male 69%
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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: Sacchromyces boulardii (250 mg capsule with 1 g S. boulardii bid (n=116) Placebo bid (n=64) Stools collected for CD culture at entry, day 5 then q 10 d, end of study, and when have diarrhea (diarrhea •3 loose/watery stools/s x 2 d); CD culture + stools were tested for cytotoxin; need 3 stools tested for CD and •8 days of monitoring for inclusion
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C. difficile Diarrhea (Diarrhea and CD Toxin +) Overall incidence of Clostridium difficile infection: Probiotic: 3/116 (2.6%) Placebo: 5/64 (7.8%) Fisher’s Exact test performed by reviewers p=0.13 Incidence of diarrhea in 48 patients had stools that were CD toxin+: Probiotic: 3/32 (9.4%) Placebo: 5/16 (31%), test of significance between groups p=0.07
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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: not defined Blinding: double Intention-to-treat analysis*: no, 138 not evaluated (43%) Withdrawals and dropouts adequately described: yes
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Results & Comparisons

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