Functional gastrointestinal disorders (FGID), such as infant regurgitation, infant colic, and functional constipation, are common and typically physiological phenomena during the early months of an infant's life and account for frequent consultations with pediatricians. Various infant formulas are marketed for their management and are frequently given by parents to infants before a medical consultation. However, the evidence supporting their effectiveness is limited and some have altered nutritional compositions when compared to standard formulas. Thus, these products should only be used under medical supervision and upon medical advice. Marketing and over-the-counter sales do not ensure proper medical guidance and supervision. The aim of this position paper is to review the current evidence regarding the safety and efficacy of formulas specifically formulated for addressing regurgitation, colic, and constipation, recognized as FGID. The objective is to provide guidance for clinical management based on the highest quality of available evidence. A wide search using Pubmed, MEDLINE, EMBASE and Cochrane Database of Systematic Reviews was performed including the MESH terms infant formula, colic, constipation, regurgitation, reflux, palmitate, lactase, lactose, magnesium, hydrolyzed protein, prebiotics or probiotics. 752 papers were identified and screened. Finally, 72 papers were included in the paper. In the absence of evidence, recommendations reflect the authors' combined expert opinion. Final consensus was obtained by multiple e-mail exchange and meetings of the Nutrition Committee. (1) For breastfed infants experiencing FGID such as regurgitation, colic, or constipation, transitioning from breastfeeding to commercial formulas is not recommended. (2) In general, whether an infant is breastfed or formula-fed, it's crucial to reassure parents that FGIDs are normal and typically do not necessitate treatment or change to a special formula. (3) Thickened formulas, often termed anti-reflux formulas, may be considered in specific cases of regurgitation. (4) The usage of specialized formulas for infants with colic is not advised due to a lack of clinical evidence. (5) In the case of constipation in infants, the use of formulas enriched with high β-palmitate and increased magnesium content may be considered to soften the stool. Generally, there is limited evidence supporting the use of specialized formulas for FGID. Breastfeeding should never be discontinued in favor of formula feeding.

Celiac Disease Research Center Tampere University Tampere Finland

Children's Hospital Helsinki University Hospital Helsinki Finland

Department of Neonatal Intensive Care Oslo University Hospital Norway Pediatric Oslo Norway

Department of Neonatology Kepler University Hospital Linz Austria

Department of Paediatrics University Hospital Motol Prague Czech Republic

Department of Patologia e cura del bambino Regina Margherita Regina Margherita Children Hospital Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino Italy

Department of Pediatric Gastroenterology Erasmus MC Sophia Children's Hospital Rotterdam Netherlands

Department of Pediatrics Tampere University Hospital Tampere Finland

Metabolic Diseases Unit Department of Pediatrics Vittore Buzzi Hospital University of Milan Milan Italy

Neonatology Hospital La Paz Institute for Health Research IdiPAZ Universidad Autónoma de Madrid Madrid Spain

Nutrition and Intestinal Failure Division Gastroenterology Department Great Ormond Street Hospital for Children NHS Foundation Trust London UK

Pediatric Hepatology Gastroenterology and Transplantation Unit ASST Papa Giovanni XXIII Bergamo Italy

Research Institute University of Oslo Oslo Norway

Serra Húnter Fellow Paediatric Nutrition and Development Research Unit Universitat Rovira i Virgili IISPV Tarragona Spain

Unit of Nutrition and Intestinal Failure Rehabilitation Department of Paediatric Gastroenterology Great Ormond Street Hospital for Children NHS Foundation Trust London UK

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