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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT04021303
Eligibility Criteria:
Inclusion Criteria:
* Healthy term infants (\>37 weeks) vaginal delivery
* Adequate birth weight for gestational age (10-90 percentile)
* Infants with normal growth curve (10-90 percentile)
* Infants who were breastfeeding for at least 4 weeks, and at least half of the takes have been by breastfeeding.
* Infants aged 4 months (+/- 1 week) at the time of study inclusion no longer following breastfeeding, or mixed breastfeeding and if they are breast-feeding, no more than one shot a day.
* Availability to continue throughout the study period.
* Signature of informed consent by partents/guardians.
Exclusion Criteria:
* Infants who were born by cesarean section
* Infants born from preconception obese mothers
* Infants born from diabetic mothers or mothers with gestational diabetes
* Infants with a family history of celiac disease (parents or siblings)
* Infants who have had or have some type of allergic manifestation or allergic pathology
* Infants who have needed antibiotic treatment or have received some type of probiotic (the week before inclusion)
* Infants with malformations, diseases or conditions and physical disabilities that cause changes in growth and/or nutritional status
* Infants diagnosed with any immune system-related disease (primary immunodeficiency)
* Infants with a known allergy and/or intolerance to cow's milk protein
* Parents' inability to follow study (at the discretion of the researcher)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
4 Months
Study:
NCT04021303
Study Brief:
Protocol Section:
NCT04021303