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 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
NCT ID:
NCT03223792
Eligibility Criteria:
Inclusion Criteria:
* Singleton 28-300 days of age at randomization
* Gestational age less than or equal to 35 weeks
* Receiving minimum 18oz infant formula in the 24hrs prior to randomization
* History of hard stools or stooling difficulty
* Signed informed consent and protected health information
Exclusion Criteria:
* Current diagnosis of cow's milk protein allergy or intolerance
* Use of extensively hydrolyzed or amino acid formula at randomization
* Any abdominal or gastrointestinal surgery prior to randomization
* History of underlying metabolic or chronic disease or congenital malformation
* Organic causes of constipation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
300 Days
Study:
NCT03223792
Study Brief:
Protocol Section:
NCT03223792