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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05369494
Eligibility Criteria:
Inclusion Criteria:
* Infant is 0 to 90 days of age at enrollment.
* Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
* Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
* Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
Exclusion Criteria:
* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development
* Awareness of a positive drug screen in the mother or participant
* Suspected maternal substance abuse including alcohol
* Participation in another study that has not been approved as a concomitant study by AN
* Participant is receiving oral or inhaled steroids
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
* Participant has received an amino acid-based formula
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
90 Days
Study:
NCT05369494
Study Brief:
Protocol Section:
NCT05369494