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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT04768933
Eligibility Criteria:
Inclusion Criteria:
1. Generally healthy toddlers born at term (37-42 weeks of gestation).
2. At enrolment visit, toddler age 12-33 months.
3. Birth weight ≥ 2500g and ≤ 4500g.
4. No known milk intolerance / allergies to cow's milk protein.
5. Habitually consuming some cow's milk or other traditional milks.
Exclusion Criteria:
1. Toddler is currently breastfed or is consuming breast milk.
2. Toddler who is experiencing growth faltering (defined as weight for length z score ≤-1.67).
3. History of preterm birth
4. Currently experiencing severe constipation.
5. Currently diagnosed with other Functional Gastrointestinal Disorders.
6. Toddlers who have known cognitive and developmental disorders.
7. Toddlers who are currently participating in or have participated in another clinical trial within 4 weeks prior to trial start.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
33 Months
Study:
NCT04768933
Study Brief:
Protocol Section:
NCT04768933