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

Inclusion Criteria

• •1. Aged between 3-8 weeks at screening.
• •2. Gestational age 37+0 weeks - 42+0 weeks at birth.
• •3. 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.
• •4. Parents/caregivers/legal guardians are \>18 years.
• •5. Exclusively or predominantly breastfed infants (\> 50 % breast fed).
• •6. Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
• •7. Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
• •8. 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.
• •9. Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
• •10. Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
• •11. The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 4 (Day 8), and Visit 6 (Day 22).
• •12. Infant is considered healthy, in the opinion of the investigator following physical exam.