Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02149134
Eligibility Criteria:
Inclusion Criteria:
* between 1 and 12 months old
* having a CMPA confirmed by a double-blind placebo controlled food challenge performed in the last 3 months, or with cow's milk allergy highly suspected based on clinical symptoms ( but not confirmed. In this case, a double blind food challenge will be performed during the first 3 months following inclusion
* whose parent(s) signed the informed consent form
Exclusion Criteria:
* Infants aged less than 1 month or more than 12 months
* Infants with eosinophilic disorders of the gastrointestinal tract
* Infants mainly or exclusively breastfed, with willingness to continue breast-feeding
* Infants having a weight at inclusion \< 2500g,
* Infants fed (at the time of inclusion or in the past) with an extensively hydrolyzed formula with no improvement of the symptoms,
* Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
* Infants fed with a vegetable based formula ,
* Infants fed an amino acid based formula
* Infants who should be fed with an amino acid based formula according to recommendations
* Infants who had an anaphylactic reaction in the past,
* Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject, such as, but not limited to , concomitant chronic systemic diseases, congenital cardiac defects, active tuberculosis, autoimmune diseases, immunodeficiency, chronic inflammatory bowel diseases, celiac disease, cystic fibrosis, metabolic diseases, lactose intolerance, malignancy, chronic pulmonary diseases, malformations of the gastrointestinal tract.
* Infants already participating in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
12 Months
Study:
NCT02149134
Study Brief:
Protocol Section:
NCT02149134