Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

Inclusion criteria

• Aged between 3-12 weeks at screening.
• Gestational age 37+0 weeks - 42+0 weeks at birth.
• Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
• Parents/caregivers/legal guardians are >18 years.
• Exclusively or predominantly breastfed infants (> 50 % breast fed).
• Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
• Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
• Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying/fussing time.
• Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
• Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
• The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).
• Infant is considered healthy, in the opinion of the investigator following physical exam.

Exclusion criteria

• Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis).
• Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container > 12x in breastfed and >5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/ legal guardians.
• Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
• Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
• Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
• Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.