Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%. The number of diagnosed cases has increased in recent years, with clinical manifestations involving the gastrointestinal tract, respiratory system, skin, or systemic reactions. Dietary elimination of cow's milk protein remains the mainstay of treatment, using extensively hydrolyzed formulas (EHF) or amino acid-based formulas (AAF), depending on the severity of the allergy.
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed whey-based formula (Almirón Pepti Syneo®) containing a symbiotic mixture (scGOS/lcFOS 9:1 and Bifidobacterium breve M-16V), the human milk oligosaccharide 2'-fucosyllactose (2'-FL), and a reduced amount of purified lactose, in infants with suspected or confirmed CMPA in a real-world clinical practice setting.
This is a prospective, longitudinal, open-label, single-arm, multicenter study including approximately 41 infants under 10 months of age at several primary care centers and one hospital in Valencia, Spain. Each participant will be followed for four weeks. A subgroup of participants will also provide stool samples to explore the effect of the study formula on gut microbiota composition.
Infants under 10 months of age at study start (Visit 1).
Suspected or recently confirmed cow's milk protein allergy (CMPA), as determined by the investigator.
Already formula-fed, or parents/legal guardians have decided to initiate formula feeding.
Inclusion in the study coincides with the first prescription of a hypoallergenic formula.
Infants with functional gastrointestinal symptoms in whom atopy or food allergy is not suspected.
Infants who have previously used an extensively hydrolyzed formula (EHF), an amino acid-based formula (AAF), a rice hydrolysate formula, or a soy-based formula.
Infants who have previously used a partially hydrolyzed formula for the prevention of cow's milk protein allergy (CMPA).
Infants for whom an amino acid-based formula (AAF) is more appropriate as first-line management, including severe forms of CMPA.
Infants under 10 months of age with suspected or recently confirmed cow's milk protein allergy (CMPA) who are initiating the use of a hypoallergenic formula as part of routine clinical management. All participants will receive an extensively hydrolyzed whey-based formula containing synbiotics and 2'-fucosyllactose (2'-FL) and will be followed prospectively for four weeks.
Cohort
Prospective
Not listed
Change in investigator-reported allergy symptom scores
Change from baseline to Week 4 in investigator-assessed allergy symptoms in infants with suspected or confirmed cow's milk protein allergy, measured using four validated or ad hoc instruments:
Change in parent-reported allergy symptom scores from baseline to Week 4
Change in parent- or caregiver-reported symptoms Differences between baseline and Week 4 will be analyzed and categorized according to improvement (reduction in score) or no improvement.
Change in stool characteristics from baseline to Week 4
Parent-reported stool characteristics (consistency and color). Frequencies of stool types will be summarized for each visit, and changes over time will be described.
Change in parental quality of life related to infant allergy from baseline to Week 4
Change in the Food Allergy Quality of Life-Parental Burden Questionnaire (FAQL-PB) score from baseline to Week 4. Improvement will be defined as a reduction in the total score. Descriptive statistics and frequencies of improvement will be presented.
Change in infant anthropometric z-scores from baseline to Week 4
Change in z-scores for weight, length, and head circumference calculated according to World Health Organization (WHO) growth standards. Differences between baseline and Week 4 will be summarized using descriptive statistics.
Changes in gut microbiota composition after 4 weeks of formula use
Stool microbiota composition assessed through 16S rRNA gene sequencing (and optional metagenomics in a subset). Outcomes include relative abundance of Bifidobacterium spp. and Bifidobacterium breve, microbiota composition (beta diversity, stability, or maturation index), microbial diversity (alpha diversity), and differential abundance of bacterial taxa from phylum to species levels.
Changes in microbial metabolites in stool samples
Concentrations and relative proportions of short-chain fatty acids levels in stool samples, measured by laboratory analysis.
Changes in microbial metabolites in stool samples
Concentrations and relative proportions of ammonia levels in stool samples, measured by laboratory analysis.
Changes in stool pH
Stool pH measured at baseline and Week 4 as an indicator of gut microbial activity and metabolic profile.
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