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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01808105
Eligibility Criteria:
Inclusion Criteria:
* Singleton from full term birth with a gestational age 37-42 weeks
* Birth weight \> 2490 g (\~5 lbs 8 oz)
* Between 0 and 5 days of age
* Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
* Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
* Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
* No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
Exclusion Criteria:
* Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
* Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
* Treatment with antibiotics
* Mother intends to use a combination of breast and formula feeding
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
5 Days
Study:
NCT01808105
Study Brief:
Protocol Section:
NCT01808105