Probiotic Products in the Pediatric Population – Available Products vs. Clinical Evidence.

Abstract

Purpose: The number of probiotic products in the food and nutraceutical market has grown dramatically in the past few years. Despite a parallel increase in publications related to probiotics in the medical literature, the data regarding their use in the pediatric population is limited and there are no clear guidelines regarding the use of probiotic products in children. Aim: To investigate the relationship between probiotic products marketed for the pediatric population in the U.S. and the published medical literature on their clinical outcome. Methods: Probiotic products marketed in the U.S. were identified using ‘ProductScan’- an online database search engine for marketed products. Using the keyword “probiotic*” we searched industries of “Foods,” “Beverages,” and “Health and Beauty Aids” for products launched between 1980 and 2008. The term “kids” was used in the “Select Product Tags or Claims” category to identify products marketed specifically for children. A PubMed search was conducted using the keyword “probiotic*” with the limits of: full text, humans, English, clinical trial, and child: 0–18 years. Articles in which study population was not predominantly children or did not have a defined clinical outcome were excluded. Brand names of probiotic products were identified if mentioned in the manuscripts. Results: I. Out of the 253 probiotic products identified through ProductScan only 26 had specific claims for use in children: 4 food products, 8 beverages, and 14 health products. II. Medical search using PubMed generated 176 articles of which 89 met the inclusion criteria following further reading to confirm eligibility. Most (N = 35) published manuscripts were related to GI conditions including diarrhea prevention (N = 11); diarrhea treatment (N = 17); necrotizing enterocolitis (N = 3); nutritional and weight (N = 3); and intestinal colic (N = 1). III. None of the 26 children-related probiotic products identified by ProductScan had a reported study identified by PubMed search. Two products found in the medical literature are available in the U.S. However, these products are not marketed directly to children and therefore were not identified in the ProductScan search. Conclusion: Only a minority of products available in the U.S. are marketed specifically for children. Most of the investigation of probiotics in children was in relation to GI conditions. The clinical outcome research showing positive results of the use of certain probiotics in the pediatric population was conducted using bacteria that are not currently marketed in the tested final product. The available probiotic products for children are not supported by evidence-based outcome research. Clinical outcome studies using available products are needed in the pediatric population.