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

Abstract

Background: Infant colic (IC) is a prevalent physiological event of infants, which can disrupt the child's home environment. We aimed to investigate the effectiveness of a mixture of Matricariae chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus (HA122) compared with Lactobacillus reuteri DSM 17938 and with simethicone for the treatment of IC. Methods:A multicenter randomized comparative study was conducted in infants with colic, according to Rome III criteria, who were randomly assigned to receive M. chamomilla L., M. officinalis L. and tyndallized L. acidophilus (HA122) (Colimil ® Plus ® ; Milte Italia Spa, Milan, Italy) (Group A), L. reuteri DSM 17938 (Group B) and simethicone (Group C). Treatment was given to subjects for 28 days.Key Results: One-hundred and seventy-six patients completed the study. Mean daily crying time at day 28 was significantly lower in group A (−44, 95% CI: −58 to −30, P<.001) and group B (−35, 95% CI: −49 to −20, P<.001) when compared to group C.No significant difference was observed between Group A and Group B (mean difference: −9 minutes, 95% CI −23 to +5, P=.205). At day 28, 39 of 57 (68.4%) of infants in Group C responded to the treatment compared with 57 out of 60 patients (95%) of Group A and 51 out of 59 (86.4%) of Group B (P<.001). Conclusions:This study suggests that administration of M. chamomilla L., M. officinalis L. and tyndallized L. acidophilus (HA122) and L. reuteri DSM 17938 are significantly more effective than simethicone in IC. Clinical Trial Registration: ClinicalTrials.gov: NCT02708238. K E Y W O R D Scomplementary and alternative medicine, herbal supplement, infantile colic, probiotics

Lactobacillus reuteri to Treat Infant Colic: A Meta-analysis

“…All included studies were double-blind randomized placebo-controlled trials of high quality. Lower-quality studies were excluded, such as the 2015 Mi et al 37 study, which was single-blind, and the 2015 Ashraf et al 38 and 2017 Martinelli et al 39 studies, which were nonblinded.…”

The Effect of Probiotics on Symptoms, Gut Microbiota and Inflammatory Markers in Infantile Colic: A Systematic Review, Meta-Analysis and Meta-Regression of Randomized Controlled Trials

“…This meta-analysis of 16 clinical trials and 1319 newborns exclusively investigated the impact of solely-probiotic interventions to reduce excessive crying in newborns manifesting symptoms of infantile colic, with no limitations on the age of study participants, and also gives a report on microbiota-related parameters affected by probiotics. Studies in which lactase, simethicone/herbal preparations or hydrolyzed formulas were utilized as probiotic comparators were not analyzed, as these interventions have their own evidence-based efficacy [59][60][61][62][63][64]. We also did not evaluate trials conducted with newborns who were not delivered at term, as premature newborns have been found to present immaturity in their digestive motility and interstitial Cajal cells [65] and are thus more prone to manifest behavioral perturbations [66].…”

Effectiveness of Herbal Medicines Containing Phytoestrogens to Treat Infantile Colic: A Meta-analysis Review

“…However due to dissatisfaction with the conventional therapeutic methods to control the infantile colic, the mothers are currently interested in herbal medicines to calm their babies colic (13). Also, herbal medicines used in the treatment of infantile colic are associated with fewer side effects.…”

“…open-label, randomized, and controlled trial (13). Diagnosis was made according to the Rome III criteria.…”

“…Measured outcomes included duration of crying, the colic improvement score, and the number of night waking times. Four trials (1,10,13,16) assessed the duration of crying. A preparation containing phytoestrogens decreased the duration of crying compared to placebo (-0.536; 95% CI=-0.848 to 0.224; P=0.001; Figure 2).…”