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)
Recruiting now
Conditions studied: Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity, Infant Nutrition Disorders, Gut Microbiota
In brief
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.
Key facts
- Study ID
- NCT07342621
- Run by
- Outcomes'10
- People needed
- 41
- Starts
- 2025-02-07
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Quironsalud Valencia Hospital — Valencia, Valencia, Spain (enrolling)
- Trinitat Health centre — Valencia, Valencia, Spain (enrolling)
- Malva-rosa Health centre — Valencia, Valencia, Spain (enrolling)
- República Argentina Health centre — Valencia, Valencia, Spain (enrolling)
- Salvador Pau Health centre — Valencia, Valencia, Spain (enrolling)
- Serrería 2 Health Centre — Valencia, Valencia, Spain (enrolling)
- Serrería I Health Centre — Valencia, Valencia, Spain (enrolling)
- Trafalgar Health centre — Valencia, Valencia, Spain (enrolling)
- Miguel Servet Health centre — Valencia, Valencia, Spain (enrolling)
- Alboraya Health centre — Valencia, Valencia, Spain (enrolling)
- Trinitat Health centre — Valencia, Valencia, Spain (enrolling)
- Cañada Health centre — Valencia, Valencia, Spain (enrolling)
- Eliana Health centre — Valencia, Valencia, Spain (enrolling)
Full record on ClinicalTrials.gov
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