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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT03679234
Eligibility Criteria:
Inclusion Criteria:
* Healthy infant
* Full-term (\> 37 weeks gestation)
* Birth weight \> 2500 and \< 4500 g
* 14-60 days of age on enrollment
* Singleton birth
* Infant's mother has elected not to breastfeed prior to enrollment
* Infant exclusively formula-fed for at least 5 days prior to enrollment
* Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
* Caregiver wishes to switch infant's formula
* Has not received solid foods
* Having obtained his/her legal representative's informed consent
Exclusion Criteria:
* Known or suspected cow-milk allergy
* Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)
* Has switched formula more than two times since hospital discharge
* Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
* Congenital illness or malformation that may affect infant feeding and/or growth
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Receiving probiotic supplements
* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
* Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
60 Days
Study:
NCT03679234
Study Brief:
Protocol Section:
NCT03679234