Advanced Search

Study Preview



Study Title and Description

Lack of effect of Lactobacillus GG on antibiotic-associated diarrhea: a randomized, placebo-controlled trial.



Key Questions Addressed
9 Key Question 9 - Probiotic or prebiotic interventions for prevention of initial and recurrent CDI
  • Comments Comments (
    0
    ) |
10 Key Question 10 - Reviews and Meta-analyses
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Lack of effect of Lactobacillus GG on antibiotic-associated diarrhea: a randomized, placebo-controlled trial.
Author Thomas MR., Litin SC., Osmon DR., Corr AP., Weaver AL., Lohse CM.
Country Division of Community Internal Medicine, Mayo Clinic, Rochester, Minn 55905, USA.
Year 2001
Numbers Pubmed ID: 11560298
1459 (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 States Randomized controlled trial
  • Comments Comments (
    0
    ) |
Sample 302 hospitalized patients on antibiotics 267 (88%) completed study Mean age (range): 56 (18-93) years Gender: Male 54%
  • Comments Comments (
    0
    ) |
Prevention of initial or recurrent Clostridium difficile infection? Primary Prevention of Initial Clostridium difficile infection
  • Comments Comments (
    0
    ) |
Intervention/Comparison and Method Probiotic: Lactobacillus GG (20 x 109 cfu + inulin filler) (CAG Functional Foods, Nebraska) 1 capsule 2x/d x 14 d (n=133) Placebo (inulin filler) (n=134)
  • Comments Comments (
    0
    ) |
C. difficile Diarrhea (Diarrhea and CD Toxin +) Overall incidence of Clostridium difficile infection: Only 5 patients (1.9%) with positive CD toxin: Probiotic: 2/133 (1.5%) Placebo: 3/134 (2.2%), p >0.99
  • Comments Comments (
    0
    ) |
Later Recurrence of CD Diarrhea
  • Comments Comments (
    0
    ) |
CD Toxin+ CD toxin in 1st 21 days after enrollment per retrospective chart review data of patients with CD at hospital Probiotic: 5/133 (4%) Placebo: 3/134 (2%), no statistical testing
  • Comments Comments (
    0
    ) |
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: CD results by randomized chart review How tested for CD toxin not reported No association of diarrhea with CD toxin+
  • Comments Comments (
    0
    ) |




Results & Comparisons

No Results found.

Extraction Form: Reviews and Meta-analyses (Table C12)
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
Focus of Review Prevention
  • Comments Comments (
    0
    ) |
Title/Question Patient Population Antibiotics and hospital- acquired C.difficile- associated diarrhea Adult inpatients
  • Comments Comments (
    0
    ) |
# of Studies Patient N 48 observational studies
  • Comments Comments (
    0
    ) |
Comparators Use of antibiotics versus multiple control group types
  • Comments Comments (
    0
    ) |
Outcomes Followup Study quality
  • Comments Comments (
    0
    ) |
Results General study quality precludes meta- analysis of observational studies for relationships between antibiotics and C. diff. 2 studies provide valid evidence for cephalosporin, penicillin, and clindamycin.
  • Comments Comments (
    0
    ) |


Baseline Characteristics
No baseline characteristics have been defined for this extraction form.



Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments

Quality Dimensions
No quality dimensions were specified.

Quality Rating
No quality rating data was found.