Health Condition 1: K929- Disease of digestive system, unspecified Health Condition 2: null- Infantile colic
Conditions
Interventions
Intervention1: oral lactase drops: five drops of lactase with 50 ml of infant formula four times in a day for 28 days
Control Intervention1: oral placebo: 5 drops of placebo added to 50 ml infant form
Sponsors
Walter Bushnell Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Apparently clinically healthy infant who is <5 months of age with infantile colic with no evidence of failure to thrive, fever or illness
Exclusion criteria
Exclusion criteria: Infants born
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of crying in minutes/day; Number of days with colic (that lasts 3 hours/day). Timepoint: Duration of crying in minutes/day; Number of days with colic (that lasts 3 hours/day). | — |
Secondary
| Measure | Time frame |
|---|---|
| Parental satisfaction (on a Likert scale); Occurrence of adverse effects (e.g. milk regurgitation, vomiting, diarrhea, constipation, drowsiness). Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDR Manish Narang
University College of Medical Sciences & GTB Hospital
Outcome results
None listed