Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales

Laboratorios Ordesa3 sites in 1 country194 target enrollmentJanuary 2011

ConditionsGastrointestinal Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Diseases
Sponsor: Laboratorios Ordesa
Enrollment: 194
Locations: 3
Primary Endpoint: Changes in diarrhea incidence
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.

Detailed Description

This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

June 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratorios Ordesa

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Full-term healthy newborns (\>= 37 weeks)
•Birth weight between \>=2.500g and \<=4.500g)
•Normal growth curve (between 3-97 percentiles)
•0-60 days of age on enrolment
•Maximum 30 days of breastfeeding
•Exclusively infant formula on enrolment
•Breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment
•Parents or caregivers agree to exclude any source of prebiotics or probiotics during the study
•Parents or caregivers agree to follow-on the study 12 weeks
•Informed consent signed ( Parent/Legal representative)

Exclusion Criteria

•Congenital illness or malformation that may affect infant feeding and /or normal growth
•Significant pre-natal or post-natal diseases
•Infant's family history of atopy
•Any pathology related to the immune or gastrointestinal system.
•Suspected or known allergy to cow's milk protein
•Infants receiving pre or probiotics within less than 15 days prior to enrolment
•Infant's family who in the investigator's assessment cannot be expected to comply with the protocol