Technical review by the ESPGHAN special interest group on gut microbiota and modifications on the health outcomes of infant formula supplemented with postbiotics.

This technical review, one of five developed by the European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) Special Interest Group (SIG) on Gut Microbiota and Modifications (GMM), supports the creation of a Paper on the use of biotic-supplemented formulas, including those containing postbiotics. Postbiotics are defined as inanimate [i.e., dead, nonviable] microorganisms and/or their components that confer health benefits to the host. This review focuses on the clinical outcomes of infant formulas supplemented with postbiotics. The SIG-GMM conducted technical review to evaluate the clinical outcomes of postbiotic-supplemented infant formulas in healthy infants (0-12 months) published before 2024. Based on the findings of a technical review, all members of the SIG voted anonymously on statements related to clinical outcomes with a score between 0 and 9. A score higher than 6 indicated agreements. A statement was rejected if <75% of the members agreed. Twelve randomized controlled trials (RCTs) met the inclusion criteria. The postbiotics studied so far showed no difference compared to the control formula in outcomes such as anthropometric data, gastrointestinal symptoms, stool characteristics, allergy, infections, tolerability and safety. The RCTs evaluating postbiotics added to infant formula are heterogeneous due to differences in study design, variations in postbiotics and durations of interventions. The studies were powered to demonstrate and did show that there was good tolerance and adequate, safe growth comparable to nonsupplemented formula in presumed healthy infants. This technical review provides the foundation for recommendations on the use of postbiotic-supplemented infant formulas in healthy infants.