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Study Title and Description

A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease.



Key Questions Addressed
7 Key Question 7 - Nonstandard intervention for treatment of initial and recurrent CDI
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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 A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease.
Author McFarland LV., Surawicz CM., Greenberg RN., Fekety R., Elmer GW., Moyer KA., Melcher SA., Bowen KE., Cox JL., Noorani Z.
Country Department of Medicinal Chemistry, School of Pharmacy, University of Washington, Seattle 98195.
Year -- Not Found --
Numbers Pubmed ID: 8201735
1409 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Key Question 4 - Nonstandard intervention for treatment of initial and recurrent CDI (Tables 19, C9)
Design Details
Question... Follow Up Answer Follow-up Answer
Comparison Adjuvant Nonstandard Intervention Versus Active Control for Recurrent Clostridium difficile infection
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Sample 124 in patients with active Clostridium difficile infection and receiving standard antibiotic treatment (vancomycin or metronidazole) 104 (84%) completed the study Mean age 58.1 Gender: Male 23% 64 patients had initial Clostridium difficile infection and 60 had recurrent 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/days x 4 weeks and standard therapy, vancomycin or metronidazole or both (n=57). Probiotic was given within 4 days of treatment Placebo and standard therapy, vancomycin or metronidazole or both (n=67). Both groups followed for 4 weeks and an additional 4 weeks Clostridium difficile infection defined as diarrhea •3 stools/d x 2 consecutive days and 1 Clostridium difficile positive assay (culture, toxin A or toxin B) Treatment failure was defined as 2 consecutive days of diarrhea, and positive Clostridium difficile assay or pseudomembranes by endoscope at time of diarrhea, diarrhea no attributable to another cause
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Resolution of Clostridium difficile infection (Diarrhea and Clostridium difficile Toxin Positive Stool) Resolution of Clostridium difficile infection Overall (all subjects, n=124) Probiotic: 73.4% (42/57) Placebo: 55.2% (37/67) p = 0.05 Subgroup analysis Subjects treated for recurrent Clostridium difficile (n=60) Probiotic 65.4% (17/26) Placebo 35.3% (12/34) p=0.04 Subjects treated for initial Clostridium difficile (n=64) Probiotic 81.3% (25/31) Placebo 75.5% (25/33) p=0.86
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Other Outcomes
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Study Quality Allocation concealment: Adequate, blinded study drug kits Blinding: double Intention-to-treat analysis: yes Withdrawals and dropouts adequately described: yes Notes: No difference in nausea, pain, or vomiting
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Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
Allocation Concealment Adequate
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Blinding Double
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Intention-to-Treat Analysis Yes
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Withdrawals and Dropouts Adequately Described Yes
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Study Quality Good
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Quality Rating
No quality rating data was found.


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
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Sample 124 in patients with active Clostridium difficile infection and receiving standard antibiotic treatment (vancomycin or metronidazole) 104 (84%) completed the study Mean age 58.1 Gender: Male 23% 64 patients had initial Clostridium difficile infection and 60 had recurrent Clostridium difficile infection
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Prevention of initial or recurrent Clostridium difficile infection? Prevention of Recurrent 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/days x 4 weeks and standard therapy, vancomycin or metronidazole or both (n=57). Probiotic was given within 4 days of treatment Placebo and standard therapy, vancomycin or metronidazole or both (n=67). Both groups followed for 4 weeks and an additional 4 weeks Clostridium difficile infection defined as diarrhea •3 stools/d x 2 consecutive days and 1 CD positive assay (culture, toxin A or toxin B) Treatment failure was defined as 2 consecutive days of diarrhea, and positive CD assay or pseudomembranes by endoscope at time of diarrhea, diarrhea no attributable to another cause
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C. difficile Diarrhea (Diarrhea and CD Toxin +)
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Later Recurrence of CD Diarrhea Probiotic: 41.3% (51/124) subjects with no recurrence Placebo: 24.3% (8/33) with initial Clostridium difficile infection had Clostridium difficile infection recurrence and 64.7% (22/34) with recurrent Clostridium difficile infection had another recurrence no statistical testing
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CD Toxin+
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Notes of Study Quality and Side Effects Allocation concealment: Adequate, blinded study drug kits Blinding: double Intention-to-treat analysis: yes Withdrawals and dropouts adequately described: yes Notes: The absence of Clostridium difficile infection recurrence for the probiotic group was reported as a percent of the entire sample and not of the probiotic group. No difference in nausea, pain, or vomiting
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Results & Comparisons

No Results found.