Efficacy & Safety of the Fixed Dose Combination of Digestive Enzymes, Carminatives and Bacillus coagulans GBI-30, 6086 in Infantile Colic

Abstract

Background: Infantile colic, characterized by repeated episodes of intense crying, is a distressing condition for parents, and its unknown etiology complicates the treatment. This study investigates the efficacy and safety of a fixed-dose combination of probiotics, digestive enzymes, and carminatives (Tummysoft Drops) in infantile colic. Methods: 108 infants (aged < 6 months) fulfilling the Rome-IV diagnostic criteria for infantile colic were randomly allocated to receive 10 drops of Tummysoft Drops (Intervention group) or placebo drops (placebo group) daily for 4 weeks. The primary outcomes of the study were reduction of the duration of crying, crying frequency, defecation frequency and the number of infants whose crying duration was reduced to > 50% from the baseline. Results: 100 Infants completed the study. At the end of 4 weeks, the mean crying duration changed from 261.30 ± 41.684 to 52 ± 12.857 min/day in the intervention group and from 262 ± 39.046 to 77 ± 27.408 min/day in the placebo group. The episodes of crying were reduced from 6.34 ± 2.387 to 0.20 ± 0.495 episodes/day in the intervention group and from 7.32 ± 2.453 to 1.30 ± 1.298 episodes/day in the placebo group. The number of infants with >50% decrease in crying time from baseline on day 14 was 49 infants in the intervention group and 30 infants in the placebo group (p = 0.05). By the end of 4th week, it was noted that parental satisfaction was better in the intervention group. Conclusion: Administration of a comprehensive formula (Tummysoft Drops) containing Bacillus coagulans GBI -30, 6086, digestive enzymes and carminatives was found to be safe and effective in the treatment of infantile colic.