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

• DOI: 10.1111/nmo.13145
• Publication Date: 2017-06-30T11:27:39Z
• Authors: M. Martinelli; D. Ummarino; F. P. Giugliano; E. Sciorio; C. Tortora; D. Bruzzese; D. De Giovanni; I. Rutigliano; S. Valenti; C. Romano; A. Campanozzi; E. Miele; A. Staiano
• Keywords: Lactobacillus reuteri; Infantile colic

Abstract Background Infant colic ( IC ) is a prevalent physiological event of infants, which can disrupt the child's home environment. We aimed to investigate effectiveness mixture Matricariae chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus HA 122) compared with reuteri DSM 17938 simethicone for treatment . Methods A multicenter randomized comparative study was conducted in infants colic, according Rome III criteria, who were randomly assigned receive M. (Colimil ® Plus ; Milte Italia Spa, Milan, Italy) (Group A), B) C). Treatment given subjects 28 days. Key Results One‐hundred seventy‐six patients completed study. Mean daily crying time at day significantly lower group (−44, 95% CI: −58 −30, P <.001) B (−35, −49 −20, when C. No significant difference observed between Group (mean difference: −9 minutes, CI −23 +5, =.205). At 28, 39 57 (68.4%) C responded out 60 (95%) 51 59 (86.4%) <.001). Conclusions This suggests that administration are more effective than Clinical Trial Registration: ClinicalTrials.gov: NCT 02708238.