To evaluate the evidence for the use of probiotics in the treatment and prevention of antibiotic-associated diarrhea.
We searched the electronic databases DARE, Cochrane Database of Systematic Reviews, CENTRAL, PubMed, EMBASE, CINAHL, AMED, MANTIS, TOXLINE, ToxFILE, NTIS, and AGRICOLA. References of key articles were screened and the International Journal of Probiotics and Prebiotics was handsearched. Current search dates are inception to August 2010, no language restrictions apply.
Types of study to be included
Condition or domain being studied
Participants of all ages treated with antibiotics regardless of the indication and the patients’ underlying symptoms.
Interventions using the genera Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, and/or Bacillus alone or in combination, using live (active or lyophilized) microorganism, in probiotic or synbiotic preparations, are eligible.
Concurrent control groups of no probiotic treatment, placebo or a different probiotic or a different dose are eligible.
We will use the primary study’s definition of diarrhea ranging from uncomplicated diarrhea to severe diarrhea with complications such as electrolyte imbalance. Outcomes such as watery stool, stool consistency, self reported and physician-defined diarrhea are eligible. Short- and long-term effects will be extracted.
Side effects of probiotic treatment.
Data extraction, (selection and coding)
Two independent reviewers will inclusion screen and assess the included studies, discrepancies will be resolved by discussion in the review team.
Risk of bias (quality) assessment
The Cochrane Risk of Bias tool will be applied. Effects of quality will be assessed in sensitivity analyses.
Strategy for data synthesis
Details of all studies meeting the inclusion criteria will be tabulated in an evidence table. In addition, we will combine trials, where clinically appropriate, in a random effects meta-analysis calculating the relative risk (RR) and the 95% confidence interval (CI) in trials reporting categorical outcomes and effect sizes and 95% CIs in trials with continuous outcomes. Where more than one active treatment group is investigated we will use the maximum probiotics dose, measured as potency and length of time, as the main treatment group. To assess heterogeneity, we will compute the I-squared statistic.
Analysis of subgroups or subsets
We will explore differential effects of the different probiotic genera, age groups (children, adults, elderly) where possible, and the clinical condition and setting.
Contact details for further information
1776 Main Street
Santa Monica, CA 90407
Organisational affiliation of the review
Dr Susanne Hempel, Rand Professor Paul Shekelle, RAND, VA, UCLA Dr Sydne Newberry, RAND Dr Ruelaz Alicia, RAND Mr Wang Zhen, Pardee RAND Graduate School
Probiotics for the prevention and treatment of antibiotic-associated diarrhea: a systematic review and meta-analysis.
Hempel S, Newberry SJ, Maher AR, Wang Z, Miles JN, Shanman R, Johnsen B, Shekelle PG.
JAMA. 2012 May 9;307(18):1959-69. Review.
Stage of review at time of this submission
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.