NCT03204630

Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: All
• Age: 3 Weeks – 5 Weeks
• Healthy volunteers: Accepted

Summary

A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota

Conditions

• Infant Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lfer	Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716
DIETARY_SUPPLEMENT	Bifido	Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263
OTHER	Control	Standard infant formula

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-11-01
• Completion: 2015-12-01
• First posted: 2017-07-02
• Last updated: 2017-07-02

Locations

2 sites across 1 country: Spain