NCT03467334

Infant Colic Treatment With Probiotics

Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Mónica Olivares Martín; PhD · Industry
• Sex: All
• Age: 3 Weeks – 12 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic. The objective of the present study is to compare the effect of B. brevis and B. brevis\\L mixture. fermentum with respect to simethicone. It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.

Conditions

• Infant Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B. breve	Bifidobacterium probiotic strain at 1E+08 cfu/day
DIETARY_SUPPLEMENT	B. breve plus L. fermentum	Probiotic combination at 2E+08 cfu/day
DRUG	Simethicone 20 MG	Standard treatment for infant colic

Timeline

• Start date: 2017-05-31
• Primary completion: 2019-06-15
• Completion: 2019-06-15
• First posted: 2018-03-16
• Last updated: 2019-07-23

Locations

1 site across 1 country: Spain