Oral lactase for infantile colic: a randomized double-blind placebo-controlled trial

Abstract

Abstract Background Infantile colic is a common problem during the first three months of life. This randomized, double-blind, placebo-controlled trial conducted in an urban hospital in Delhi, India evaluated the efficacy and safety of oral lactase in management of infantile colic. Methods One hundred sixty-two clinically healthy infants aged 3 h/d; secondary outcomes were parental satisfaction and adverse events. Results At the end of four weeks, mean (SD) crying or fussing time (min/d) was significantly shorter in infants receiving lactase in comparison to placebo [89.9 (115.2) vs.178.5 (153.2); P = 0.001]. The mean (SD) number of days with colic was also significantly less in the lactase group as compared to placebo group at the end of the treatment [12.1 (7.8) vs 17.6 (8.4); P < 0.001]. By the end of 4th week, parental satisfaction in terms of infant’s mood, activity, alertness, comfort and oral intake was better in intervention group. The adverse event profile was comparable between two groups. Conclusions Oral lactase treatment in infantile colic results in symptomatic relief in terms of shortening of duration of crying or fussing, and better parental satisfaction. Trial registration Clinical trial registry of India (CTRI/2017/12/010930) registered on 20/12/2017.

Keywords

• Crying
• Fussy infant
• Infantile colic
• Lactase
• Treatment