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:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03222804
Eligibility Criteria:
Inclusion Criteria:
* Women with infants age 8 to 12 weeks
* Term infants born \>37 weeks gestation
* Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA or within a 20-mile UCDMC
* Women and infants who live in one location
* Infants born vaginally
* Infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed
* Women who are mixed and formula feeding their infants who are willing to switch infant formulas and use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) throughout the first two months of the study
* Women who are breastfeeding but introduce infant formula to their infants during the first two months of the study who are willing to use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) for the first two months of the study
Exclusion Criteria:
* Women who have lived in the United States or other developed nation for less than 10 consecutive years
* Multiple infants born to one mother
* Plan to feed infants solid foods before infants turn 5 months of age
* Family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy
* Infants born by C-section
* Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
* Infants who have taken antibiotics 4 weeks before enrollment and more than one course of antibiotics since birth
* Infants who have taken probiotics since birth
* Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants for the first two months of the study
* Mothers who have a chronic metabolic disease or obesity
* Mothers who currently smoke or plan to resume smoking during the study period
* Infants who consume solid foods or other liquids other than breastmilk, infant formula or water
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT03222804
Study Brief:
Protocol Section:
NCT03222804