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Study Title and Description

Clostridium difficile pilot study: effects of probiotic supplementation on the incidence of C. difficile diarrhoea.



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 Clostridium difficile pilot study: effects of probiotic supplementation on the incidence of C. difficile diarrhoea.
Author Plummer S., Weaver MA., Harris JC., Dee P., Hunter J.
Country Cultech Ltd., York Chambers, York Street, Swansea, SA1 3NJ, United Kingdom. sue.cultech@btinternet.com
Year 2004
Numbers Pubmed ID: 15179608
1460 (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 Kingdom Randomized controlled trial
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Sample 150 elderly hospitalized patients started on antibiotics 138 (92%) completed study Age and gender not reported
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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: Lactobacillus acidophilus and Bifidobacterium bifidum, 2 x 1010 cfu in 1 capsule/d (Cultech, Saansea) for at least 20 of antibiotic therapy (n=69) Placebo (n=69) Start therapy within 36 hours of antibiotics, probiotic = 1.12 days after antibiotics placebo = 1.10 day Stools were cultured for C. difficile, then if culture +, CD toxins A and B were tested - at start of study - if diarrhea - after antibiotics completed during hospitalization or discharge
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C. difficile Diarrhea (Diarrhea and CD Toxin +) CD diarrhea, 1st testing, during diarrhea and antibiotic tx in hospital: Probiotic: 2/69 (3%) Placebo: 5/69 (7%), no statistical testing reported, Fisher’s Exact test performed by reviewers p=0.44 Proportion developing diarrhea positive for CD toxins was 4.35% lower in probiotic group (95% CI of -0.132 to 0.038). CD diarrhea, 2nd testing of same patients after antibiotics completed or at discharge: Probiotic: 2/69 (3%) Placebo: 6/69 (9%)
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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 Withdrawals and dropouts adequately described: no Notes: Diarrhea is undefined Study participation stopped if on antibiotics >20 days
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Results & Comparisons

No Results found.