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Study Title and Description

The search for a better treatment for recurrent Clostridium difficile disease: use of high-dose vancomycin combined with Saccharomyces boulardii.



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 The search for a better treatment for recurrent Clostridium difficile disease: use of high-dose vancomycin combined with Saccharomyces boulardii.
Author Surawicz CM., McFarland LV., Greenberg RN., Rubin M., Fekety R., Mulligan ME., Garcia RJ., Brandmarker S., Bowen K., Borjal D., Elmer GW.
Country Division of Gastroenterology, Department of Medicine, University of Washoington, Seattle, WA USA. surawicz@u.washington.edu
Year 2000
Numbers Pubmed ID: 11049785
1407 (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 168 randomized adult inpatients and outpatients with recurrent Clostridium difficile infection, 32 on high-dose vancomycin (This paper reported subgroup analysis of treatment of subjects on high-dose vancomycin only) Recurrent Clostridium difficile infection subjects Mean age (years): 61.6 Gender: Male (M) 41%
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Intervention/ Comparison and Method Probiotic-Sacchromyces boulardii (1 g/d) + high dose oral vancomycin (2g/d) (n=16) Placebo (1 g/d) + high dose oral vancomycin (2g/d) (n=16) Probiotic/placebo started on day 7-day 28 Clostridium difficile infection was defined as diarrhea (•3 loose/watery stools/s x 2 days or >8 loose stools/day within 48 hours) and positive Clostridium difficile assay (culture then toxin A or B) measured at multiple time points
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Resolution of Clostridium difficile infection (Diarrhea and Clostridium difficile Toxin Positive Stool) Probiotic and vancomycin: 13/16 (81.3%) Placebo and vancomycin: 8/16 (50%) Fisher’s Exact test performed by reviewers p =0.06
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Other Outcomes
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Study Quality Allocation concealment: adequate, centralized Blinding: double Intention-to-treat analysis: yes Withdrawals and dropouts adequately described: none reported
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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 (none reported)
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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 Randomized controlled trial
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Sample 32 randomized adult inpatients and outpatients, 32 with recurrent Clostridium difficile infection CD disease subjects Age: 61.6 Gender: Male 41%
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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 Clostridium difficile infection subjects Probiotic: S. boulardii (1 g/d) + high dose oral vancomycin (2g/d) (n=16) Placebo (1 g/d) + high-dose oral vancomycin (2g/d) (n=16) Probiotic/placebo started on day 7 - day 28 Clostridium difficile infection = diarrhea + (•3 loose/watery stools/s x 2 days or >8 loose stools/day within 48 hours) and positive CD assay (culture then toxin A or B) measured at multiple time points
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C. difficile Diarrhea (Diarrhea and CD Toxin +)
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Later Recurrence of CD Diarrhea Recurrence: Probiotic: 3/18 (17%) Placebo: 7/14 (50%), p=0.05
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CD Toxin+
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Notes of Study Quality and Side Effects Allocation concealment: adequate, centralized Blinding: double Intention-to-treat analysis: yes Withdrawals and dropouts adequately described: none reported
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Results & Comparisons

No Results found.