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Oral lactase for infantile colic: a randomized double-blind placebo-controlled trial
1Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, University College of Medical Sciences (University of Delhi) and Guru Teg Bahadur Hospital, Delhi, India. manish_2710@yahoo.com.
Insights
Oral lactase significantly reduced crying time and colic days in infants. This treatment improved parental satisfaction with no increase in adverse events, offering an effective management option for infantile colic.
Area of Science:
- Pediatrics
- Gastroenterology
- Clinical Trials
Background:
- Infantile colic is a prevalent condition affecting infants in their first three months of life.
- Management of infantile colic often presents challenges for healthcare providers and parents.
- Evaluating novel therapeutic interventions for infantile colic is crucial.
Purpose of the Study:
- To assess the efficacy and safety of oral lactase for managing infantile colic.
- To determine the impact of oral lactase on infant crying duration and colic frequency.
- To evaluate parental satisfaction with oral lactase treatment.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted with 162 infants diagnosed with infantile colic.
- Infants received either oral lactase (600 FCC units/mL) or a placebo for four weeks.
- Primary outcomes included duration of crying/fussing and days with colic; secondary outcomes were parental satisfaction and adverse events.
Main Results:
- Infants receiving oral lactase showed a significant reduction in crying/fussing time (89.9 min/d vs. 178.5 min/d; P=0.001).
- The number of days with colic was significantly lower in the lactase group (12.1 days vs. 17.6 days; P<0.001).
- Parental satisfaction improved, and adverse events were comparable between the lactase and placebo groups.
Conclusions:
- Oral lactase provides symptomatic relief for infantile colic by reducing crying and fussing duration.
- The treatment leads to improved parental satisfaction regarding infant well-being.
- Oral lactase is a safe and effective option for managing infantile colic.
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 < 5 months age [mean (SD) = 63.5 (30.5) days] fulfilling the Rome-IV diagnostic criteria for infantile colic were enrolled. Eligible children were randomly allocated to receive 5 drops of lactase (600 FCC units/mL) (n = 80) or placebo (n = 82) mixed with breast milk or formula feed four times a day for a duration of 4 weeks. Primary outcomes were duration of crying or fussing (min/d), and number of days with colic lasting > 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.
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