Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies-An Open-Label Randomized Study

Malgorzata Bernatek, Jacek Piątek, Marcin Pszczola, Hanna Krauss, Janina Antczak, Paweł Maciukajć, Henning Sommermeyer, Malgorzata Bernatek, Jacek Piątek, Marcin Pszczola, Hanna Krauss, Janina Antczak, Paweł Maciukajć, Henning Sommermeyer

Abstract

The aim of this study (ClinicalTrials.gov registration NCT04666324) was to determine the effects of a nine-strain synbiotic and simethicone on the duration of crying and the gut inflammation marker calprotectin in colicky babies aged 3-6 weeks, diagnosed using the Wessel criteria. The open-label study comprised a control group of non-colicky babies (n = 20) and two parallel treatment groups (each n = 50) to which colicky babies were randomly and equally assigned to receive the multi-strain synbiotic or simethicone orally for 28 days. Primary outcome measures were the change in daily crying duration and the level of fecal calprotectin on days 1 and 28 of the study. Administration of the synbiotic resulted in a rechange of crying duration of -7.18 min/day of treatment, while simethicone had a significantly smaller effect (-5.74 min/day). Fecal calprotectin levels in colicky babies were significantly elevated compared to those in non-colicky babies. Treatment with the nine-strain synbiotic resulted in a significant lowering of fecal calprotectin at the end of the study, while no such effect was found for simethicone. No adverse effects were reported. Study results confirm earlier findings of crying duration reductions in colicky babies by the synbiotic, an effect that might be linked to its anti-inflammatory properties.

Keywords: colic; colicky babies; crying; dysbiosis; fecal calprotectin; gut inflammation; gut microbiota; infantile colic; simethicone; synbiotic.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Patient enrollment and study progress.
Figure 2
Figure 2
Effects of simethicone or multi-strain synbiotic treatment in colicky babies on daily crying duration over the course of the treatment.
Figure 3
Figure 3
Fecal calprotectin levels in the control, simethicone, and multi-strain synbiotic groups on day 1 (before treatment) and on day 28 (at end of the treatment period) of the study. Different lowercase letters indicate significant differences between groups (p < 0.05).

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