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:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT01067027
Eligibility Criteria:
Inclusion Criteria:
* Ifants aged between 14 and 60 days
* Breast fed, exclusively during length of trial
* Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
* Debut of colic symptoms 6+/-1 days before randomization
* Gestational age between 37 and 42 weeks
* Apgar score higher than 7 at 5 minutes
* Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
* Written informed consent from one or both parents
* Stated availability throughout the study period
Exclusion Criteria:
* Major chronic disease
* Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
* Administration of anitbiotics the week before randomization
* Administration of probiotics the week before randomization
* Participation in other clinical trials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
60 Days
Study:
NCT01067027
Study Brief:
Protocol Section:
NCT01067027