Infantile colic Signs and Symptoms Infantile colic
Conditions
Interventions
At enrollment, each infant underwent a medical examination by a pediatrician, and parents completed a questionnaire to obtain data concerning type of delivery, birth weight, and gestational age. The p
Sponsors
Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 2 and 10 weeks 2. Gestational age between 37 and 40 weeks 3. Birth weight between 2700 g and 4200 g, 4. Exclusively breastfed 5. Colic, as diagnosed according to the Wessel definition modified by Roma IV criteria (infants have at least three episodes of unexplained full-force crying lasting more than three hours per day on at least three days a week for at least one week) 6. Maternal willingness and ability to avoid dietary cow’s milk
Exclusion criteria
Exclusion criteria: 1. Clinical evidence of chronic illness or gastrointestinal disorders 2. Antibiotic or probiotic treatment in the week preceding recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colic measured by changes in the parent-reported crying time per day of infants at baseline and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut inflammation assessed using real-time PCR analysis of gut microbiota from fecal samples, and fecal calprotectin levels measured via a quantitative assay at baseline and 28 days | — |
Countries
Italy
Outcome results
None listed