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|
Primary Publication Information
|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. firstname.lastname@example.org|
Pubmed ID: 17604300
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)
|Question... Follow Up||Answer||Follow-up Answer|
|Country / Study Design||Randomized controlled trial|
|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%|
|Prevention of initial or recurrent Clostridium difficile infection?||Primary Prevention of Initial Clostridium difficile infection|
|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)|
|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)|
|Later Recurrence of CD Diarrhea|
|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|
Results & Comparisons
No Results found.