Infant colic Neonatal Diseases
Conditions
Interventions
Prior to the start of the study, the allocation of subject numbers to study groups will be performed by randomization. Randomization will be stratified by infant age (=6 weeks versus >6 weeks). The ra
Sponsors
Chr. Hansen A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infant colic defined as crying or fussing episodes lasting more than 3 hours per day and occurring at least 3 days per week within 7 days prior to enrollment (ROME III) 2. Exclusive breast fed infants at inclusion 3. Less than 3 months of age 4. Greater than 37 weeks gestation at birth 5. Birth weight of more than 2500 g
Exclusion criteria
Exclusion criteria: 1. Formula fed or combination breast fed/ formula fed infants 2. Failure to thrive (weight gain < 100 grams/week averaged from birth to the last recorded weight) 3. Major medical problems (e.g. ill, immunocompromised, major developmental or genetic abnormality 4. Gastrointestinal disorder 5. Taking antibiotics four weeks prior to enrollment 6. Using probiotics in the past two weeks prior to enrollment 7. Taking antibiotics during intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of infants achieving a reduction in the daily crying/fussing time after 3 weeks treatment. Measured daily in diary. Baseline will be the mean of crying and fussing time measured daily in the diary during run in (day -7 to -1). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stool frequency and consistency, measured daily in diary using Amsterdam Stool Form. Baseline will be the mean frequency and consistency measured daily in the diary during run in (day -7 to -1) 2. Faecal IgA and calprotectin, measured at baseline (before intervention, day -1) and end of intervention (day 21) | — |
Countries
China
Outcome results
None listed