The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Formula

Infant formula with a novel probiotic CECT7210

Group Type EXPERIMENTAL

Infant Formula with a novel probiotic CECT7210

Intervention Type DIETARY_SUPPLEMENT

Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.

Standard Formula

Standard infant formula without probiotics

Group Type ACTIVE_COMPARATOR

Standard formula

Intervention Type DIETARY_SUPPLEMENT

Standard formula without probiotics

Interventions

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Infant Formula with a novel probiotic CECT7210

Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.

Intervention Type DIETARY_SUPPLEMENT

Standard formula

Standard formula without probiotics

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes