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Study Title and Description

Lactobacillus plantarum 299v for the treatment of recurrent Clostridium difficile-associated diarrhoea: a double-blind, placebo-controlled trial.



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 Lactobacillus plantarum 299v for the treatment of recurrent Clostridium difficile-associated diarrhoea: a double-blind, placebo-controlled trial.
Author Wullt M., Hagslätt ML., Odenholt I.
Country Department of Infectious Diseases, University Hospital Malmö, Malmö, Sweden. marlene.wullt@skane.se
Year 2003
Numbers Pubmed ID: 12953945
1408 (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 29 adult patients with recurrent disease from 9 centers (positive Clostridium difficile toxin assay within 6 days of enrollment at least 1 prior episode Clostridium difficile diarrhea within past 2 months and ongoing diarrhea). 8 patients (28%) lost to followup were not included in analysis, 21 completed trial (72%) Mean age: 63.8 Gender: Male 5%
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Intervention/ Comparison and Method Probiotic-Lactobacillus plantarum in fruit drink with oats fermented by L. plantarum 299v (5 x 1010 cfu) x 38 days and Metronidazole (400 mg three times per day po) x 10 d Placebo fruit drink with chemically acidified oats and metronidazole Toxin testing on days 11-13 followup about diarrhea on days 37-41 and 70-75 Clinical cure was defined as no diarrhea (•3 loose stools x 2 days) on days 5-10 of treatment:
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Resolution of Clostridium difficile infection (Diarrhea and Clostridium difficile Toxin Positive Stool) Probiotic and metronidazole: 92% (11/12) Placebo and metronidazole: 100% (9/9) No statistical testing reported, Fisher’s Exact test performed by reviewers p=1.0
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Other Outcomes
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Study Quality Allocation concealment: Not defined Blinding: double Intention-to-treat analysis: no Withdrawals and dropouts adequately described: yes Notes: Clostridium difficile toxin not measured after day 11
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Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
Allocation Concealment Not defined
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Blinding Double
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Intention-to-Treat Analysis No
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Withdrawals and Dropouts Adequately Described Yes
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Study Quality Fair
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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 Randomized controlled trial
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Sample 29 adult patients from 9 centers with + CD toxin assay within 6 days of enrollment at least 1 prior episode Clostridium difficile infection diarrhea within past 2 months. And ongoing diarrhea 8 patients (28%) lost to followup were not included in analysis, 21 completed trial Mean age: 63.8 years Gender: Male 5%
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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 Probiotic: L. plantarum in fruit drink with oats fermented by L. plantarum 299v (5 x 1010 cfu) x 38 days and Metronidazole (400 mg tid po) x 10 days Metronidazole + placebo fruit drink with chemically acidified oats
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C. difficile Diarrhea (Diarrhea and CD Toxin +) Clinical cure: no diarrhea (• 3 loose stools x 2 days) on days 5-10 of tx Probiotic: 11/12 (92%) Placebo: 9/9 (100%)
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Later Recurrence of CD Diarrhea Total recurrences: Probiotic: 4/11 (36%) Placebo: 6/9 no statistical testing reported, Fisher’s Exact test performed by reviewers p=0.37
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CD Toxin+ CD toxin negative: Probiotic:7/1 2 (58%) Placebo: 5/9 (56%), p=.642
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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: yes
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Results & Comparisons

No Results found.