Infantile abdominal colic Signs and Symptoms Other and unspecified abdominal pain
Conditions
Interventions
Participants will be randomized to receive the following treatments over two 10-day periods with a 4-day washout period between treatments:
1. Lactase (Colief) treated milk feeds (4 drops of solution
Sponsors
Crosscare Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female babies between the ages of 21 and 90 days inclusive at time of study entry 2. Born at a gestational age of at least 32 weeks and with a birth weight of at least 2000 g 3. Symptoms of abdominal colic for at least 3 hours per day for at least 3 days per week present over the preceding 2 weeks 4. Associated signs of spasm and/or lower limb flexure and/or diarrhoea 5. Otherwise healthy babies 6. Parents/guardians willing to consent to their baby participating in the study 7. Exclusively bottle-fed babies
Exclusion criteria
Exclusion criteria: 1. Age 90 days at date of study entry 2. Born at <32 weeks gestation or with birth weight <2000 g 3. Any significant congenital disorder 4. Any significant co-existing disease 5. Partially breast-fed 6. Receiving any other anti-colic medicines 7. Known intolerance to beta-galactosidase (lactase)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crying time, measured in minutes from diary cards completed by parents/guardians over each 10-day treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fussing/fretting time 2. Stool frequency 3. Overall parent evaluation Measured from the diary cards completed by parents/guardians during each 10-day treatment period | — |
Countries
Australia, Hong Kong, United Kingdom, United States of America
Outcome results
None listed