Technical review by the ESPGHAN Special Interest Group on Gut Microbiota and Modifications on the health outcomes of infant formula supplemented with probiotics.

This technical review, one of the five developed by the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) Special Interest Group on Gut Microbiota and Modifications (SIG-GMM), supports the preparation of a paper on the use of biotic-supplemented formulas, including those containing probiotics. The SIG-GMM conducted this review of studies published before December 31, 2023, to evaluate the clinical outcomes of administering probiotic-supplemented infant formulas to healthy infants (0-12 months). Following the review, all 20 members of the SIG-GMM anonymously assigned scores of 0-9 for each statement related to probiotic-supplemented infant formula. A score ≥6 indicated agreement with a statement, but a statement was rejected if 75% of the members concurred regarding its rejection. The systematic review included 28 studies on the effects of probiotic-supplemented infant formulas. The probiotics 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 studies varied in terms of probiotic strains, study designs, and intervention durations. The trials, primarily conducted in Western countries, demonstrated that probiotic-supplemented formulas were well tolerated, with no significant differences in anthropometric parameters and in the growth of infants compared to those fed nonsupplemented formulas in presumed healthy infants. Some evidence suggests potential benefits of probiotic-supplemented formulas in reducing gastrointestinal and respiratory infections, although the findings were inconsistent. This technical review provides the foundation for recommendations on the use of probiotic-supplemented infant formulas in healthy infants.