The Effect of Probiotics on Symptoms of Infantile Colic

The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)

The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.

Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.

The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.

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 cry or 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, and with expressed or implied consent of the other parent.
6. With parents willing to complete questionnaires, records, and diaries associated to the 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 after birth.
5. Stunted growth/weight loss (< 100 g/week from birth to last reported).
6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.
7. Fever and/or infectious diseases, or current systemic infections, or history of congenital 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 infant at 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 the moment of screening.
16. Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.