The Effect of Probiotics on Symptoms of Infantile Colic

Inclusion Criteria:

1. Healthy male or female.
2. Age ≤ 8 weeks old.
3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cryor fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
4. Exclusively breastfeeding and planning to breastfeed for duration of study.
5. With a written informed consent signed by the father, mother, or legal guardian, andwith expressed or implied consent of the other parent.
6. With parents willing to complete questionnaires, records, and diaries associated tothe study and to complete all clinical visits and telephone calls.

Exclusion Criteria:

1. Birthweight < 2500 g.
2. Gestational age < 37 weeks.
3. Apgar score at 5 minutes < 7.
4. Partially or fully formula fed infants, with the exception of the first 4 days afterbirth.
5. Stunted growth/weight loss (< 100 g/week from birth to last reported).
6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases orgastrointestinal malformations.
7. Fever and/or infectious diseases, or current systemic infections, or history ofcongenital infections.
8. Genetic diseases and chromosomal abnormalities.
9. Metabolic diseases or pancreatic insufficiency.
10. Immunodeficiency.
11. Neurological diseases.
12. Suspected or confirmed food allergies and intolerances.
13. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infantat any time from birth to the moment of screening.
14. Use of anti-colic medication at any time from birth to the moment of screening.
15. Use of probiotic supplements by the mother between the birth of their infant and themoment of screening.
16. Currently enrolled in another clinical study or having participated in anotherclinical trial from birth to the moment of screening.