drugset
drugset / Trial / NCT03467334

Infant Colic Treatment With Probiotics

NCT03467334 ↗

Phase 2 Completed 156 enrolled Mónica Olivares Martín; PhD European Regional Development Fund · collabMinisterio de Ciencia e Innovación, Spain · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2017-05-31
Primary completion
2019-06-15
Completion
2019-06-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Simethicone Other / unclassified 20 mg —

Indications

No indication recorded.