Amino acid-based formula with synbiotics for cow's milk protein allergy: a real-world study of symptom evolution and quality-of-life outcomes

Background: Cow's milk protein allergy (CMPA) is a common early-life food allergy. Evidence from routine care settings may complement randomized trials by describing symptom trajectories in heterogeneous populations. Objective: This study aimed to describe changes in symptom scores and caregiver-reported outcomes over 28 days following initiation of an amino acid-based formula containing synbiotics in infants with suspected or confirmed CMPA in routine practice. Methods: This was a prospective, multicenter, observational, single-arm real-world cohort study. Physicians recorded cow's milk allergy symptom score (CoMiSS) and infant gastrointestinal symptom questionnaire (IGSQ-13) at baseline (Day 1) and Day 28. Caregivers completed the atopic dermatitis patient-oriented score (PO-SCORAD) and quality of life in food allergy-parental burden (FAQL-PB) at baseline and Day 28 and recorded stool, regurgitation, and discomfort at prespecified time points. One-year outcomes (growth and health resource use) were assessed descriptively among participants with available follow-up data. Results: A total of 71 infants completed the 28-day observation period. Mean CoMiSS decreased from 10.1 (SD 4.6) at baseline to 3.5 (SD 2.2) on Day 28. Median IGSQ-13 and PO-SCORAD scores decreased over 28 days; FAQL-PB scores also decreased. Caregiver-reported stool frequency and regurgitation categories improved over time. One-year outcomes were available for 56 children and are reported descriptively. Conclusion: In this prospective real-world cohort, symptom scores and caregiver-reported outcomes improved over 28 days following initiation of an amino acid-based formula containing synbiotics in infants managed for suspected/confirmed CMPA. Given the observational nature of the study, these findings should be interpreted cautiously and do not establish causality or comparative effectiveness.