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

Area of Science:

• Pediatrics
• Gastroenterology
• Microbiology

Background:

• Infant colic is a common condition characterized by excessive crying.
• Gut inflammation, indicated by elevated fecal calprotectin, may play a role in infant colic.
• Current treatments for colic have varying efficacy and potential side effects.

Purpose of the Study:

• To evaluate the efficacy of a nine-strain synbiotic compared to simethicone in reducing crying duration in colicky infants.
• To assess the impact of the synbiotic and simethicone on fecal calprotectin levels, a marker of gut inflammation.
• To compare the effects of synbiotic and simethicone on crying duration and gut inflammation in infants aged 3-6 weeks.

Main Methods:

• An open-label study involving non-colicky controls (n=20) and colicky infants (n=100) randomly assigned to synbiotic or simethicone for 28 days.
• Primary outcomes included changes in daily crying duration and fecal calprotectin levels on days 1 and 28.
• Wessel criteria were used for colic diagnosis; ClinicalTrials.gov registration NCT04666324.

Main Results:

• The nine-strain synbiotic reduced crying duration by -7.18 min/day, significantly more than simethicone (-5.74 min/day).
• Colicky infants exhibited elevated fecal calprotectin compared to controls.
• Synbiotic treatment significantly lowered fecal calprotectin, while simethicone did not. No adverse effects were reported.

Conclusions:

• A nine-strain synbiotic effectively reduces crying duration in colicky infants.
• The synbiotic's anti-inflammatory properties may contribute to its efficacy in managing infant colic.
• Synbiotics represent a promising therapeutic option for infant colic, potentially addressing underlying gut inflammation.