Extensively hydrolysed whey formula with synbiotics and 2'-FL for infants with cow's milk protein allergy
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)
This study tests whether an extensively hydrolysed whey-based infant formula with synbiotics and the human milk sugar 2'-fucosyllactose (2'-FL) helps infants under 10 months who have suspected or confirmed cow's milk protein allergy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 41 (estimated) |
| Ages | N/A to 10 Months |
| Sex | All |
| Sponsor | Outcomes'10 Research network |
| Locations | 13 sites (Valencia, Valencia and 12 other locations) |
| Trial ID | NCT07342621 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Infants under 10 months with suspected or recently confirmed CMPA who are formula-fed or whose caregivers have chosen to start a hypoallergenic formula and who have not previously received hydrolysed or amino acid-based formulas.
Not a fit: Infants with severe CMPA who require an amino acid-based formula, those with non-allergic functional gastrointestinal problems, infants previously treated with hydrolysed/AAF formulas, or those outside the enrollment age window are less likely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the formula could reduce CMPA symptoms while supporting normal infant growth and favorably modifying gut microbiota.
How similar studies have performed: Previous trials of similar extensively hydrolysed formulas containing synbiotics and HMOs have reported safety and symptom improvement and supported growth, though longer-term and broad real-world microbiota effects remain under study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Valencia, Valencia and 12 other locations
- 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)
- Serrería I Health Centre — Valencia, Valencia, Spain (Recruiting)
- Trafalgar Health centre — Valencia, Valencia, Spain (Recruiting)
- Miguel Servet Health centre — Valencia, Valencia, Spain (Recruiting)
- Alboraya Health centre — Valencia, Valencia, Spain (Recruiting)
- Trinitat Health centre — Valencia, Valencia, Spain (Recruiting)
- Cañada Health centre — Valencia, Valencia, Spain (Recruiting)
- Eliana Health centre — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Mónica Rodríguez, Medical Manager Peads
- Email: monica.rodriguez@danone.com
- Phone: 662 150 840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.