Guide to Designing, Conducting, Publishing, and Communicating Results of Clinical Studies Involving Probiotic Applications in Human Participants

Published in: Gut Microbes, v. 1, no. 4, July/Aug. 2010, p. 243-253

Posted on on July 15, 2010

by Andi L. Shane, Michael D. Cabana, Stephane Vidry, Dan Merenstein, Ruben Hummelen, Collin L. Ellis, James T. Heimbach, Susanne Hempel, Susan V. Lynch, Mary Ellen Sanders, et al.

Read More

Access further information on this document at

This article was published outside of RAND. The full text of the article can be found at the link above.

The heterogeneity of human clinical trials to assess the effectiveness of probiotics presents challenges regarding interpretation and comparison. Evidence obtained from clinical trials among a population with disease or specific risk factors may not be generalizable to healthy individuals. The evaluation of interventions in healthy persons requires careful selection of outcomes due to the absence of health indicators and the low incidence of preventable conditions. Given the tremendous resources invested in such trials, development of consistent approaches to assessing the effectiveness of probiotics would be beneficial. Furthermore, the reporting, presentation, and communication of results may also affect the validity of the scientific evidence obtained from a trial. This review outlines the challenges associated with the design, implementation, data analysis, and interpretation of clinical trials in humans involving probiotics. Best practices related to their design are offered along with recommendations for enhanced collaboration to advance research in this emerging field.

This report is part of the RAND Corporation external publication series. Many RAND studies are published in peer-reviewed scholarly journals, as chapters in commercial books, or as documents published by other organizations.

The RAND Corporation is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.