Phase 4
N=180
Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics
Infantile Colics
Bottom Line
View on ClinicalTrials.gov: NCT02708238 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Median Daily Crying Time at the End of the Treatment — 50; 55; 80 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122) (Dietary_supplement); Lactobacillus reuteri DSM 17938 (108 CFU) (Dietary_supplement); Simethicone (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Federico II University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Daily Crying Time at the End of the Treatment |
50; 55; 80 | — |
| SECONDARY Number of Responders |
57; 47; 38 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02708238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.