Protocol for a randomized trial comparing a synbiotic-enriched goat milk-based infant formula with a commercially available cow milk-based formula: effects on gastrointestinal symptoms, quality of life, and growth in infants with cow milk-related symptoms.

backgroundsGoat milk-based formulas (GMFs) may improve digestion and gastric emptying, as suggested by in vitro studies. Probiotics like Bifidobacterium animalis BB-12 enhance microbiota balance, while prebiotics stimulate beneficial bacteria growth, and beta-palmitate supports fat absorption and stool consistency. This pragmatic study aims to evaluate the impact of a GMF with synbiotics and beta-palmitate, compared to a commercially available CMF, on the severity and frequency of gastrointestinal, as well as other associated symptoms, and the quality of life in infants who exhibit symptoms that may be related to cow milk. METHODS AND ANALYSIS: It is a randomized controlled trial involving healthy, exclusively formula-fed infants aged 14 to 90 days, previously on CMF for at least 7 days, with Cow Milk-related Symptom Score (CoMiSS) between 6 and 10. Participants will be randomly allocated to GMF or CMF for 4 weeks. The primary outcome is the change in CoMiSS after 2 weeks. Secondary outcomes include percentages of infants with changes in CoMiSS, scores on the Pediatric Quality of Life Inventory, severity and frequency of gastrointestinal symptoms measured by the Infant Gastrointestinal Symptom Questionnaire, growth parameters, stool parameters, and adverse events. The study protocol was approved by the Ethics Committee of the Medical University of Warsaw. The findings will be submitted to a peer-reviewed journal and presented at relevant conferences. DISCUSSION: By comparing a study product to a commercially available formula, this pragmatic trial directly addresses real-world decision-making in infant formula selection. The findings will expand the understanding of the effects of a GMF enriched with synbiotics and beta-palmitate on cow milk-related symptoms in infants, potentially providing valuable insights for clinical practice. TRIAL REGISTRATION NUMBER: NCT06108401.