RecruitingNot Applicable

SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)

Spain41 participantsStarted 2025-02-07

Plain-language summary

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.

Who can participate

Age range10 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Written informed consent obtained from parents or legal guardians in accordance with local regulations. Exclusion Criteria: * 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. * Contraindications to the use of synbiotics (e.g., preterm infants \<40 weeks of corrected gestational age at study start, immunodeficiency, short bowel syndrome, parenteral nutrition, post-pyloric feeding, central venous catheter, oncology treatment, or graft-versus-host disease). * Any other condition, as assessed by the investigator, that contraindicates the use of an extensively hydrolyzed formula. * Any other circumstance, as assessed by the investigator, indicating that the p…

What they're measuring

Change in investigator-reported allergy symptom scores

Timeframe: Baseline (Visit 1) and Week 4 (Visit 2)

Trial details

NCT IDNCT07342621

SponsorOutcomes'10

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-03-31

Contact for this trial

Mónica Rodríguez, Medical Manager Peads

662 150 840 monica.rodriguez@danone.com