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Study Title and Description

Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial.



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 Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial.
Author Hickson M., D'Souza AL., Muthu N., Rogers TR., Want S., Rajkumar C., Bulpitt CJ.
Country Nutrition and Dietetic Research Group, Faculty of Medicine, Imperial College, London W12 0HS. mhickson@hhnt.nhs.uk
Year 2007
Numbers Pubmed ID: 17604300
1487 (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 Randomized controlled trial
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Sample 135 hospital patients taking antibiotics were given tx until tx was finished + 1 week; If discharged from hospital and stayed on antibiotics, they continued tx; CD testing and followup occurred for 4 weeks after tx ended 11/2002-1/2005 22 (16%) patients lost to followup and not included in the analyses 12 in probiotic group and 10 in placebo 4 pts not tested for CD (1 on probiotics and 3 on placebo) Mean age: 74 years Gender: Male 46%
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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: L. casei DN-114 001 (L casei imunitass, 1 x 108 cfu/ml) + S.thermophilus (1 x 108 cfu/ml) + L. bulgaris (1 x 107 cfu/ml) in yogurt drink (Actimel, Danone, FR) (n=69) Placebo: sterile milkshake (Yazoo, Campina NE) (n=66) Drinks consumed during antibiotics therapy + 1 week CD toxins A and B tested in diarrheal stools CD diarrhea = CD toxins A and/or B and diarrhea stools (2 liquid stools/d x 3 or more days in an amount greater than normal for the patient)
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C. difficile Diarrhea (Diarrhea and CD Toxin +) Overall incidence of Clostridium difficile infection: Probiotic: 0/57 Placebo: 9/53 (17%), p=0.001 Absolute risk reduction = 17% (95% CI 7% to 27%) NNT = 6 (4 to 14)
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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: adequate (pharmacy - controlled) Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts adequately described: yes Notes: Good compliance with drink, 75% for probiotic and 79% placebo Type CD toxin not specified No adverse events from either drink
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Results & Comparisons

No Results found.