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

This technical review—one of five developed by the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Special Interest Group on Gut Microbiota and Modifications (SIG-GMM)—supports the preparation of a position paper on the use of biotic- and synbiotic-supplemented infant formulas. This paper also presents the statements made by the SIG-GMM after performing a technical review to evaluate the clinical effects of synbiotic-supplemented infant formulas in healthy full-term infants (0–12 months), as emerged from studies published before 2024. The review focused on the following clinical outcomes (if available): anthropometric measurements, safety, tolerability, stool frequency and consistency, infantile colic or crying, gastrointestinal symptoms, infections and antibiotic use, and allergic disorders. Following the review, all members of the SIG anonymously voted on each statement, scoring them between 0 and 9. A statement was accepted when ≥75% of the members scored >6. The technical review identified 16 randomized controlled trials that evaluated the clinical effects of synbiotic-supplemented infant formula in healthy full-term infants. The studies varied in terms of synbiotic composition, study design, intervention duration, and outcomes. Formulas supplemented with synbiotics studied so far were well tolerated and showed no significant difference compared to the non-supplemented formulas in growth parameters, gastrointestinal symptoms, stool characteristics, or safety. This technical review serves as the background for formulating recommendations on the use of synbiotic-supplemented infant formula in healthy infants studied so far.