An observational study in Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders and Malabsorption/Maldigestion, sponsored by Société des Produits Nestlé (SPN). Completed at 29 sites in United States. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Observational
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's enrollment of 144 is above the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The intent of the program is to enroll infants consuming a free amino acid based infant formula identified in the US
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Infants who use a free amino acid based Infant formula during their first year of life including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who will be fed a free amino acid based infant formula
Adverse events
To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula
Time frame: 4 months
Clinical characteristics
To describe the demographic and clinical characteristics of infants fed a free amino acid based infant formula
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Jan 2019, 24 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN) →