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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT02586558
Eligibility Criteria:
Inclusion Criteria:
* Healthy, term infant from a singleton birth (=\>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour
Exclusion Criteria:
* Infants with known genetic syndromes; birth weight (\<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
8 Weeks
Study:
NCT02586558
Study Brief:
Protocol Section:
NCT02586558