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

2022-02-12
Microorganisms 10(2)

PubMed: 35208884
DOI: 10.3390/microorganisms10020430

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 50
Population: colicky babies aged 3-6 weeks, diagnosed using the Wessel criteria, and a control group of non-colicky babies (n = 20)
Methods: 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

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.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Lacticaseibacillus casei R0215	—	Reduced Crying Duration	Beneficial	Moderate	View source 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).
Lacticaseibacillus casei R0215	—	Reduced Fecal Calprotectin	Beneficial	Moderate	View source 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.
Lactobacillus casei R0215	—	Reduced Crying Duration	Beneficial	Moderate	View source 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).
Lactobacillus casei R0215	—	Reduced Fecal Calprotectin	Beneficial	Moderate	View source 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.