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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT04140604
Eligibility Criteria:
Inclusion Criteria:
* Having informed consent of the parent or legal guardian.
* Healthy male and female infants between 7 days and 2 months (60 ± 2 days) of age at the time of study initiation.
* Full term ( ≧ 36 weeks gestation at birth).
* Birth weight ≧ 2500 g.
* Able and willing to comply with all study requirements.
Exclusion Criteria:
* Failure to thrive (weight gain \< 100 grams/week average from birth to the last recorded weight).
* Major acute or chronic illness (e.g. significant cardiac, respiratory, hematological, gastrointestinal or other systemic diseases, major developmental or genetic abnormality).
* Use of substances that alter gut microbiota (antibiotics, prebiotics, probiotics or gastric acid inhibitors) within 2 weeks prior to the study initiation.
* For breastfed infants, use of antibiotics, prebiotics and probiotics by the mothers.
* Cow's milk protein allergy.
* Feeding difficulties.
* History of any allergies to maltodextrin.
* Participation in another clinical trial.
* Any other clinically significant medical, psychiatric and/or social reason as determined by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Days
Maximum Age:
60 Days
Study:
NCT04140604
Study Brief:
Protocol Section:
NCT04140604