Preventive Effects of Synbiotic Oral Supplementation on Infant Colic: A Prospective Randomized Clinical Trial Study

Abstract

Background: Infantile colic (IC) is a common functional gastrointestinal (GI) disorder that significantly affects infants and their families. Recent evidence suggests that modulation of gut microbiota through synbiotic supplementation may alleviate colic symptoms. Objectives: This study aimed to survey two parallel-groups clinical trial was therefore designed to evaluate the preventive effects of synbiotic supplementation on the incidence of infant colic, maternal quality of life, and infant fecal calprotectin levels. Methods: In a triple-blind, randomized, placebo-controlled trial, 104 healthy full-term infants aged < 10 days, and without antibiotic exposure were assigned to receive either 10 drops of a synbiotic supplement or placebo daily for 8 weeks. Outcomes included incidence of colic, maternal quality of life [short form health survey (36 items; SF-36)], fecal calprotectin levels, and infant colic behaviors, recorded using a validated Barr diary. Results: A total of 83 infants completed the study (Synbiotic group = 39, Placebo group = 44). A clinically meaningful reduction in the incidence of colic (15.4% synbiotic group, 29.5% placebo group) and maternal pain was seen in the synbiotic group (P = 0.04). Fecal calprotectin levels, crying duration, and restlessness decreased in both groups, but between-group differences were not statistically significant. No effect was found on infant growth parameters. Conclusions: Preventive synbiotic supplementation may have beneficial clinical effects on reducing colic incidence and improving maternal comfort, though larger studies are needed to confirm these findings and explore underlying mechanisms.