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 range

10 Months

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Cow's Milk Protein Allergy (CMPA) trials