Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics
Infantile Colics
About this trial
This is an interventional treatment trial for Infantile Colics focused on measuring Infantile colics
Eligibility Criteria
Inclusion Criteria:
- diagnosis of IC according to Rome III criteria (2);
- age ≥2 weeks to 4 months;
- breast-fed or fomula-fed infants;
- term delivery (≥37 weeks gestation at birth);
- 5-minute Apgar score ≥7; and 6) birth weight ≥2500 g
Exclusion Criteria:
- a major medical problem or acute illness;
- family history of atopy;
- history of antibiotic treatment before or during the study;
- history of probiotic supplementation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Group A
Group B
Group C
All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution
All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension
All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 15 drops two times per day of a commercially available solution