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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01809951
Eligibility Criteria:
Inclusion Criteria:
* infants of 6 - 12 months of age
* full term infants
* birth weight more than 2500 grams
* infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements
* subject is prescribed a soy-based infant formula by physician
Exclusion Criteria:
* established/suspected hypersensitivity fo soy
* presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease
* history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases
* presence of severe gastrointestinal disorder
* subject is participating in any interventional clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Months
Study:
NCT01809951
Study Brief:
Protocol Section:
NCT01809951