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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT00929292
Eligibility Criteria:
Inclusion Criteria:
* Healthy term infants with a gestational age ranging from 37 to 42 weeks
* Non breastfed children
* Infants with normal growth
* Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
* These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
* Apgar score \> 5 to 7 minutes
Exclusion Criteria:
* Infants with severe regurgitations
* Newborn currently participating in another trial
* Infants presenting a metabolic, nervous or organic disease able to interfere with the study
* Infants presenting lactose intolerance
* Evidence of protein cow's milk allergy
* Mother who wants to keep breasfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
3 Months
Study:
NCT00929292
Study Brief:
Protocol Section:
NCT00929292