The effect of probiotic supplements on infants with crying/fussing caused by digestive problems (colic)

INTERVENTION: 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, comprising a sunflower oil suspension of the strains B. longum CECT7894 (KABP042) and P. pentosaceus CECT8330 (KABP041), contains 1 billion Colony‐Forming Units (CFU) in each drop (1:1 for the two strains). Five drops (equal to 1 billion CFU) are taken once daily preferably at the same time of the day, e.g. in the morning. The reference product (placebo) is an identical sunflower oil without probiotics. Both the probiotics and the placebo are produced by AB‐Biotics S.A. Caregivers administer five drops of the study product orally to each infant daily for 21 days. The dose is not required to be given at a fixed time or given with feeds. However, for compliance and ease of administration, each family is recommended to give the dose with the same feed each day. The total duration of follow‐up for all study arms is 13 months. Randomization: A blocked randomization schedule that maintains a balance between treatment arms will be prepared by an independent statistician, not directly involved in the analysis of the study results. The RAND function of Excel (Microsoft, Redmond, WA, USA) will be used to generate randomly permutated codes. To minimize potential biases, the study is double‐blinded whereby treatment allocation is concealed from all study investigators and participants. CONDITION: Colic ; Signs and Symptoms ; Colic PRIMARY OUTCOME: Mean daily crying or fussing time measured using parental self‐report each day of the intervention SECONDARY OUTCOME: ; 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; 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