Extensively hydrolysed whey formula with synbiotics and 2'-FL for infants with cow's milk protein allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, longitudinal, open-label, single-arm multicenter study follows infants prescribed an extensively hydrolysed whey-based formula (Almirón Pepti Syneo®) that contains a synbiotic mixture (scGOS/lcFOS 9:1 and Bifidobacterium breve M-16V), the human milk oligosaccharide 2'-FL, and reduced purified lactose. Physicians will report clinical outcomes related to cutaneous, respiratory, and gastrointestinal CMPA symptoms and track growth in routine clinical visits across hospital and primary care settings. Eligible infants are under 10 months, are formula-fed or are starting formula, and have suspected or recently confirmed CMPA, with exclusions for prior use of hydrolysed, amino-acid, rice, or soy formulas or cases requiring amino acid-based formulas. The single-arm, real-world design captures physician-reported effectiveness and tolerability in everyday practice rather than through randomized comparison.

Why it matters

Who can join: the full rules

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 parents or legal guardians are not capable of complying with the study procedures.

Where it's running

• Quironsalud Valencia Hospital
  Valencia, Valencia, Spain Recruiting
• Trinitat Health centre
  Valencia, Valencia, Spain Recruiting
• Malva-rosa Health centre
  Valencia, Valencia, Spain Recruiting
• República Argentina Health centre
  Valencia, Valencia, Spain Recruiting
• Salvador Pau Health centre
  Valencia, Valencia, Spain Recruiting
• Serrería 2 Health Centre
  Valencia, Valencia, Spain Recruiting

Study contacts

• Study coordinator: Mónica Rodríguez, Medical Manager Peads
• Email: monica.rodriguez@danone.com
• Phone: 662 150 840

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.