Colic Signs and Symptoms Colic
Conditions
Interventions
All eligible colic infants are randomized to receive either the probiotics as the intervention group (IG) or a reference product without probiotics as the placebo group (PG). The probiotic formula, co
Sponsors
Angel Children’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 IV criteria) 2. Less than 3 months (12 weeks) of age 3. Equal to or greater than 37 weeks of gestation at birth 4. Vaginal delivery 5. Birth weight of more than 2500g 6. Provided voluntary written informed consent from parents of the infant
Exclusion criteria
Exclusion criteria: 1. Average weight gain < 100 grams/week from birth to the last recorded weight 2. Major medical problems (e.g. immunocompromised disease, major developmental or genetic abnormality) 3. Gastrointestinal disorder 4. Taking antibiotics four weeks prior to enrollment 5. Using the same probiotic strains in this study two weeks prior to enrollment 6. Taking antibiotics during the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean daily crying or fussing time measured using parental self-report each day of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of daily episodes of crying or fussing measured using parental self-report each day of the intervention. 2. Infant quality of life measured using the pediatric quality of life inventory at the 7th, 14th and 21st day after the intervention | — |
Countries
China
Outcome results
None listed