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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03877458
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of infantile colic (ie, crying or fussy/gassy episodes ≥3 hours/day for ≥3 days/7 days, as defined by a modified definition of Wessel criteria) at study commencement.
2. Age 3 weeks to 3 months at study commencement.
3. Infants are born in full term (greater than 37 weeks) and the birth weight more than 2500 grams.
Exclusion Criteria:
1. A major medical problem or acute illness, including gastroesophageal reflux, as determined by a pediatrician.
2. History of antibiotic treatment before or during the study.
3. History of probiotic supplementation.
4. History of any allergies to any of the ingredients in the probiotic mixture of L. acidophilus, B. longum and B. bifidum or placebo.
5. Concurrent participation in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
3 Months
Study:
NCT03877458
Study Brief:
Protocol Section:
NCT03877458