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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT01721850
Eligibility Criteria:
Inclusion Criteria:
* Healthy term infants
* Subjects appropriate for gestational age between 35 and 41 weeks
* Subjects between 15-60 days old
* Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)
* Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
* Subjects exclusively bottle-fed at study entrance
* Day care of the child only by mother/father
* Provide written informed consent in accordance with legal requirement
Exclusion Criteria:
* Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
* Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
* Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
* Subjects receiving formula for special medical purposes
* Exclusively breast-fed infants
* Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion
* Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
* Participation in any other clinical intervention
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Days
Maximum Age:
60 Days
Study:
NCT01721850
Study Brief:
Protocol Section:
NCT01721850