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
Observational Study
Cow's Milk Protein Allergy (CMPA)
Food Hypersensitivity
Infant Nutrition Disorders
Gut Microbiota
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- Up to 10 Months
- Sex
- Any
- Study type
- Observational
- Participants needed
- 41 (estimated)
- Sponsor
- Outcomes'10 · Research network
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About This Trial
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 exten…
Trial Locations
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Eligibility 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…
Contacts