Effect of Probiotics on Infantile Colic Symptoms

Launched by LALLEMAND HEALTH SOLUTIONS · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a specific probiotic called B. lactis B94 might help reduce crying and fussiness in infants with a condition known as infantile colic. Infantile colic is when a baby cries for more than three hours a day, for more than three days in a week, and it can be very stressful for both babies and their parents. The researchers are hoping that babies who receive the probiotic will cry less after four weeks compared to those who receive a placebo, which is a treatment that doesn’t contain the active ingredient.

To be eligible for the trial, babies must be healthy, under 8 weeks old, and exclusively breastfeeding. Parents must be willing to fill out questionnaires and attend scheduled visits. However, babies with certain health issues, like low birth weight or infections, cannot participate. If you think your baby might qualify, you can expect to be involved in regular check-ins and to help provide valuable information that could help improve treatment for infantile colic in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.
• • I4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.
• • I5. With a written informed consent signed by the father and mother or legal guardian.
• • I6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.
• • I7. At least one of the legal representatives is affiliated with a social security scheme.
• Exclusion Criteria:
• • E1. Birthweight \< 2500 g. E2. Gestational age \< 37 weeks. E3. Apgar score at 5 minutes \< 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.
• • E5. Stunted growth/weight loss (\< 100 g/week from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.
• • E7. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
• • E8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances. E13. Mother who consumed antacid medications (proton pump inhibitor and H2 receptor antagonist) within the month before birth and intend to consume any during the trial.
• • E14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.
• • E15. Use of anti-colic medication at any time from birth to the moment of screening.
• • E16. Use of probiotics and prebiotics supplements by the mother between the birth of their infant and the moment of screening and intend to consume any during the trial.
• • E17. Currently enrolled in another clinical study or having participated in another clinical from birth to the moment of screening.
• • E18. Whose legal representatives have psychological or linguistic incapability to sign the informed consent.
• • E19. Impossibility to contact the legal representatives in case of emergency.