Role of Lactase in Infantile Colic
Not Applicable
Completed
- Conditions
- Health Condition 1: K929- Disease of digestive system, unspecifiedHealth Condition 2: null- Infantile colic
- Registration Number
- CTRI/2017/12/010930
- Lead Sponsor
- Walter Bushnell Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
Infants born < 34 weeks, or with birth weight < 2500 grams or inadequate weight gain (125 grams/week); gastrointestinal disorders; previous abdominal surgery; acute illness; anaphylaxis; galactosemia and diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of crying in minutes/day; Number of days with colic (that lasts 3 hours/day). <br/ ><br>Timepoint: Duration of crying in minutes/day; Number of days with colic (that lasts 3 hours/day). <br/ ><br>
- Secondary Outcome Measures
Name Time Method Parental satisfaction (on a Likert scale); Occurrence of adverse effects (e.g. milk regurgitation, vomiting, diarrhea, constipation, drowsiness). <br/ ><br>Timepoint: 4 weeks