At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of infantile colic according to Rome III criteria
- ✓Age 2 weeks to 4 months
- ✓Breast-fed or formula-fed infants
- ✓Term delivery (≥37 weeks gestation)
- ✕Major medical problem or acute illness
- ✕Family history of atopy
- ✕Antibiotic treatment before or during the study
- ✕Prior probiotic supplementation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of a Standardized Extract of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) Compared With Lactobacillus Reuteri (DSM 17938) and With Simethicone for the Treatment of Infantile Colic
In Brief
A Phase 4 clinical trial evaluating Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), Lactobacillus reuteri DSM 17938 (108 CFU), and 1 other intervention for Infantile Colics. Completed, enrolled 180 participants.
Detailed Summary
A multicenter prospective, randomized comparative study will be conducted in infants with colic, according to Rome III criteria. Enrolled infants will be assigned at random to receive Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), L reuteri DSM 17938 (108 CFU) or simethicone. Treatment will be given to subjects for 28 days and they will be followed for 4 weeks. Treatment success will be assessed at the end of study period. Daily crying and fussing times will be recorded in a structured diary, and maternal questionnaires will be completed to monitor changes in infant colic symptoms and adverse events.