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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT03477669
Eligibility Criteria:
Inclusion Criteria:
* Caregiver is able to give written informed assent and willingness to participate in the study and comply with its procedures
* Male or Female
* Born at term (38-41 weeks gestation)
* Aged 3 wks-16 wks
* Be in generally good health as determined by the investigators
* BMI between 5th and 95th percentiles
* Exclusively breastfeeding throughout the study
* Be willing to complete crying diary
* Be willing to administer the probiotic as prescribed
* Be willing to completed the Quality of Life instrument before and after the intervention
* Meets the Rome criteria for colic
Exclusion Criteria:
* Are less than 3 weeks or greater than 17 weeks of age or older
* Underweighted or obese based on BMI. Less than 5th or greater than 95th percentiles
* Mothers on an exclusively vegan diet and those with a chronic disease requiring medication therapy
* Mothers or infants having a significant acute or chronic existing illness \[cardiovascular, gastrointestinal, immunological\] or a condition, which in the investigators judgment contraindicates involvement in the study
* Mothers or infants having a condition or taking a medication, dietary supplement or food product that the investigator believes would interfere with the objectives of the study pose a safety risk or confound the interpretation of the study results
* Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial
* Mothers or infants who are receiving treatment involving experimental drugs
* Participation in a recent experimental trial less than 30 days prior to this study
* Inability to complete the diary, survey scales and appointments
* First degree relative allergic to ragweed, asters, or chrysanthemums
* The following concomitant medications are not allowed at any time during or 1 week prior to initiation of the study: antibiotics or probiotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
16 Weeks
Study:
NCT03477669
Study Brief:
Protocol Section:
NCT03477669