Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Simethicone

Criteria

Inclusion Criteria:

1. diagnosis of IC according to Rome III criteria (2);

2. age ≥2 weeks to 4 months;

3. breast-fed or fomula-fed infants;

4. term delivery (≥37 weeks gestation at birth);

5. 5-minute Apgar score ≥7; and 6) birth weight ≥2500 g

Exclusion Criteria:

1. a major medical problem or acute illness;

2. family history of atopy;

3. history of antibiotic treatment before or during the study;

4. history of probiotic supplementation.