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

NCT03204630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2017-07-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    collaborator OTHER

  • Andaluz Health Service

    collaborator OTHER_GOV

  • Biosearch S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
5 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-11-30
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204630 on ClinicalTrials.gov