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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT05555004
Eligibility Criteria:
Inclusion Criteria:
1. Child is between 24 months to 36 months of age.
2. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
3. Healthy status based on medical history and physical examination
4. Weight- for-age and height-for-age within normal range on local childhood growth chart.
5. Written informed consent are obtained from both parents/legally authorized representative (LAR).
6. Parents/legally authorized representative must be able to provide evidence of the parental authority and identity.
7. Parents /legally authorized representative are of legal age of consent and must understand the informed consent and other study documents.
8. Parents/legally authorized representative are willing and able to fulfill the requirements of the study protocol.
Exclusion Criteria:
1. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or significant food allergies that impact a normal diet.
2. Prior to study participation, child has shown limited or no interest in drinking toddler milk.
3. Chronic infectious, gastrointestinal, metabolic, or genetic disease, including any disease/condition that impacts feeding or growth.
4. Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
5. Child is currently consuming or has consumed any formulas or taking any supplement containing L. reuteri in the past 3 months.
6. Child is currently consuming or has consumed any formulas or taking any supplement containing GOS within the past 48 hrs prior to product in take, and who are not willing accept a temporary cessation of the consumption during the study period.
7. Child is currently participating in another investigational clinical trial.
8. Family or hierarchical relationships with the CIL team.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Months
Maximum Age:
36 Months
Study:
NCT05555004
Study Brief:
Protocol Section:
NCT05555004