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Study Title and Description

Failure of dietary oligofructose to prevent antibiotic-associated 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 Failure of dietary oligofructose to prevent antibiotic-associated diarrhoea.
Author Lewis S., Burmeister S., Cohen S., Brazier J., Awasthi A.
Country Department of Medicine, Addenbrooke's Hospital, Cambridge, UK. sjl@dircon.co.uk
Year 2005
Numbers Pubmed ID: 15709999
1461 (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 450 hospital patients •65 years prescribed a broad spectrum antibiotic within past 24 hours 15 (3.3%) patients withdrew or were withdrawn from study N=435 who finished Mean age (range): 77 (70-84) years Gender: Male 49%
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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 Prebiotic: Oligofructose (12 g/d) (n=215) Placebo (sucrose 12 g/day) (n=220) Taken during antibiotics + 7 days after Follow up for additional 7 days C difficile toxin was measured if diarrhea (1-2 loose stools/day)
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C. difficile Diarrhea (Diarrhea and CD Toxin +) 54 (12%) patients were culture-positive for C. difficile on study entry. Prebiotic: 19/213 (9%) Placebo: 21/220 (9.5%), no statistical testing reported, Fisher’s Exact test performed by reviewers p=0.87
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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: Unclear Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts adequately described: yes Notes: Subjects were withdrawn from study if they experienced significant diarrhea (>3 stools/day) Stated intent to treat but some % are for N=433 not 435 or 450 who enrolled No increase in bloating, stool form or interval between stools by prebiotic
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Results & Comparisons

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