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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT03667118
Eligibility Criteria:
Inclusion Criteria:
* healthy infants, ≥ 5 months but \< 11 months of age whose parent/caregiver can provide, in English, consent, understand instructions and complete a daily diet diary for their child, answer questions about how much and in what food they mix the Food supplement, and report any reaction or adverse event. Pregnant women will not be excluded if they have a child who is eligible for the study.
Exclusion Criteria:
* \- Any parent/caregiver who cannot provide consent.
* Any parent/caregiver who cannot understand or write English.
* A parent/caregiver who is in prison.
* Any infant who
* Has a previous or current diagnosis of food allergy, made by a board-certified allergy and immunology specialist;
* Was born before 37 weeks of pregnancy (premature birth);
* Has severe eczema, as determined by two parent/caregiver questions:
1. During the past 6-11months, have you been told by a doctor or other health professional that your infant has eczema or any kind of skin allergy? (National Health Interview Survey, 2012) If yes, go to Question 2.
2. Would you describe (his/her) eczema or skin allergy as mild, moderate, or severe? (National Survey of Children's Health, 2007) If described as severe, infant is excluded.
* Has a current serious, chronic condition, as measured by:
1. Does you infant have a health condition that has lasted for more than three (3) months? If yes, go to Question 2.
2. Has your infant been hospitalized more than 2 times since birth for this condition? If yes to Question 1 and 2, infant is excluded.
* If a parent/caregiver has multiple birth infants (e.g., twins), only one eligible infant will be selected.
* Any person who works for Before Brands or who has a family member working for Before Brands.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Months
Maximum Age:
11 Months
Study:
NCT03667118
Study Brief:
Protocol Section:
NCT03667118