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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02138656
Eligibility Criteria:
Inclusion Criteria:
* Parentally-reported crying of more than three hours per day for three or more days in the preceding week (reported at initial contact to determine preliminary diagnosis of colic)
* Confirmation at first clinic visit that the infant has cried for more than three hours per day for at least one day in the base-lining period.
* Otherwise normal infants, born at term, with normal growth and development, and no indication of other underlying pathology
* Parents fluent in English, providing informed written consent
Exclusion Criteria:
* Infants who have received previous chiropractic, osteopathic or other manipulative treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
12 Weeks
Study:
NCT02138656
Study Brief:
Protocol Section:
NCT02138656