Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study.

2021-06-15
Beneficial microbes 12(3)

PubMed: 33765904
DOI: 10.3920/bm2020.0160

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 87
Population: 87 infants aged 3-6 weeks with infantile colic
Methods: Open-label, two parallel treatment group study; randomly, unequally [1:1.5] assigned to receive simethicone (n=33) or a multi-strain synbiotic (n=54) orally for 4 weeks

Rigorous Journal

The aim of the study was to determine effects of administration of simethicone and a multi-strain synbiotic on the crying behaviour of colicky babies. The study design consisted of an open-label, two parallel treatment group study involving 87 infants aged 3-6 weeks with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 3 weeks prior to enrolment) randomly, unequally [1:1.5] assigned to receive simethicone (n=33) or a multi-strain synbiotic (n=54) orally for 4 weeks. The multi-strain synbiotic contained Lactobacillus acidophilus LA-14, Lacticaseibacillus casei R0215, Lacticaseibacillus paracasei Lp-115, Lacticaseibacillus rhamnosus GG, Ligilactobacillus salivarius Ls-33, Bifidobacterium lactis Bl-04, Bifidobacterium bifidum R0071, Bifidobacterium longum R0175 and fructooligosaccharides). Primary outcome measures were the responder rates (effect ≥50% reduction from baseline) of the measures 'crying days last 3 weeks', 'average evening crying duration last 3 weeks' and 'reduction of average number of crying phases per day last three weeks' at the end of treatment. The study is registered at ClinicalTrials.gov under NCT04487834. Significantly higher responder rates (effect ≥50% reduction from baseline) of the multi-strain synbiotic compared to simethicone were found for the measures 'crying days last 3 weeks' (72% vs 18%, P<0.0001) and 'average evening crying duration last 3 weeks' (85% vs 39%, P=0.0001). No significant difference was found for the measure 'reduction of average number of crying phases per day last three weeks' (50% vs 42%, P=0.4852). No adverse effects were reported for the two treatment groups. Based on these results, the multi-strain synbiotic can be considered as an interesting therapeutic possibility for the treatment of infantile colic, worthwhile to be investigated further in non-clinical and clinical studies.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Lacticaseibacillus casei R0215	—	No Adverse Effects	Beneficial	Small	View source No adverse effects were reported for the two treatment groups.
Lacticaseibacillus casei R0215	—	Reduced Average Number of Crying Episodes	Neutral	Small	View source No significant difference was found for the measure 'reduction of average number of crying phases per day last three weeks' (50% vs 42%, P=0.4852).
Lacticaseibacillus casei R0215	—	Reduced Crying in Infants	Beneficial	Large	View source Significantly higher responder rates (effect ≥50% reduction from baseline) of the multi-strain synbiotic compared to simethicone were found for the measures 'crying days last 3 weeks' (72% vs 18%, P<0.0001) and 'average evening crying duration last 3 weeks' (85% vs 39%, P=0.0001).
Lactobacillus casei R0215	—	Reduced Crying	Beneficial	Moderate	View source Significantly higher responder rates ... of the multi-strain synbiotic compared to simethicone were found for the measures 'crying days last 3 weeks' (72% vs 18%, P<0.0001) and 'average evening crying duration last 3 weeks' (85% vs 39%, P=0.0001).