Infant Colic Treatment With Probiotics

• Status: Completed
• Trial end date: 2019-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mónica Olivares Martín; Mónica Olivares Martín; PhD
• Collaborators: European Regional Development Fund; Ministerio de Ciencia e Innovación, Spain
• Treatments: Simethicone

Criteria

Inclusion Criteria:

• Infants from 3 to 12 weeks of age

• Born at least at week 34

• Birth weight equal to or greater than 2000 grams

• Fulfill the criteria of Rome III

• Informed consent signed by parents or guardians

Exclusion Criteria:

• Failure to thrive

• Antibiotic treatment less than 2 weeks before the study or during the study

• Take probiotics as a treatment, different from the one that could contain the powdered infant formula

• Abandon breastfeeding and switch to infant formula

• Failure to comply with the study protocol