A critical appraisal of probiotics (as drugs or food supplements) in gastrointestinal diseases

Abstract

Probiotics may be registered as food supplements or drugs. This article summarizes differences in European regulations of probiotics registered as food supplements and drugs, as well as issues related to the quality of probiotic products. For registration as a drug, the European Medicines Agency demands extensive and detailed quality, efficacy and safety evidence; whereas compulsory analyses requested for food supplements consist only in a nutritional analysis. As a result, the quality of those probiotics registered as drugs, compared to food supplements, is in general controlled with higher standards. Despite these differences and whatever the status of the probiotic product, its efficacy and safety has to be documented in well conducted randomized controlled trials (RCTs). Furthermore, this paper reviews recent evidence on the use of probiotics for gastrointestinal diseases, evaluating all the existing information up to January 2014. In all eligible published studies in which use of probiotics for gastrointestinal diseases were investigated and reported, no language limitations were applied. Special focus is placed on RCTs (or their meta-analyses) showing positive results, so that the findings may be applicable to everyday clinical practice. Currently, the best documented clinical areas appear to be probiotics efficacy for the treatment of acute gastroenteritis in children and for the prevention of antibiotic-associated diarrhea both in children and in adults. In other gastrointestinal conditions, some promising observations are emerging, but no definitive conclusions can be reached at present.

Keywords::

• Diarrhea
• Drug
• EFSA regulation
• Food supplement
• Probiotics

Transparency

Declaration of funding

This study was sponsored by Biocodex.

Declaration of financial/other relationships

A.P. and P.M. have disclosed that they are consultants to Biocodex. P.A. is Biocodex International Medical Affairs Manager.

CMRO peer reviewers on this manuscript have received an honorarium for their review work, but otherwise have no relevant financial or other relationships to disclose.

Notice of Correction:

The version of this article published online ahead of print on 13 March 2014 contained errors in Figure 1. References 44 and 45 were cited erroneously in the figure and there were some minor typographical and layout errors. The errors have been corrected for this version.