Effects of a Nine Strain Bacterial Synbiotic compared to Simethicone in Colicky Babies – An Open-label Randomized Study

ABSTRACT

Objective: To determine effects of administration of simethicone and a multi strain synbiotic on the crying behavior of colicky babies.

Study design: 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 enrollment) were 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. Study registered at ClinicalTrials.gov under NCT 04487834.

Results:  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.

Conclusion: 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.