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:
NCT02094092
Eligibility Criteria:
Inclusion Criteria:
* All infants (Full term with gestational age \> 37 weeks and \< 41 weeks) aged \<3 months with infantile colic (defined as crying episodes lasting 3 or more hours/day and occurring at least 3 days/week within 7 days prior to enrollment)
* Infants who were exclusively or predominantly (\>50%) breastfed/fed on Fresh Milk i.e.; cow milk/buffalo/tetra pack.
Exclusion Criteria:
* Acute or chronic illness
* Gastrointestinal disorders
* Use of any antibiotics and/or probiotic pharmaceutical products within 7 days prior to the study.
* Infants taking Probiotic containing infant formula milks.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Months
Study:
NCT02094092
Study Brief:
Protocol Section:
NCT02094092