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

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.

Timeline

Start

2014-04

Primary completion

2015-07

Completion

2015-07

Publications

• Martinelli M, Ummarino D, Giugliano FP, Sciorio E, Tortora C, Bruzzese D, De Giovanni D, Rutigliano I, Valenti S, Romano C, Campanozzi A, Miele E, Staiano A. Efficacy of a standardized extract of Matricariae chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus (HA122) in infantile colic: An open randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12). doi: 10.1111/nmo.13145. Epub 2017 Jun 30.

Drugs

Indications

No indication recorded.