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

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

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Infant Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bifido

Infant formula containing Bifidobacterium breve CECT7263

Group Type ACTIVE_COMPARATOR

Bifido

Intervention Type DIETARY_SUPPLEMENT

Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263

Lfer

Infant formula containing Lactobacillus fermentum CECT5716

Group Type ACTIVE_COMPARATOR

Lfer

Intervention Type DIETARY_SUPPLEMENT

Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716

Control

Standard infant formula

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Standard infant formula

Interventions

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Lfer

Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716

Intervention Type DIETARY_SUPPLEMENT

Bifido

Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263

Intervention Type DIETARY_SUPPLEMENT

Control

Standard infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
* Signature of informed parental or guardian consent.

Exclusion Criteria

* Allergic to the protein in cow's milk.
* Lactose intolerant.
* Suffering from a serious metabolic disease.
* They have experienced or are experiencing some severe gastrointestinal disease.
* Receive some form of chronic medication or are receiving antibiotics at the time of capture.
* Low expectation of compliance with the study protocol.
* allergic to any group of antibiotics.

Minimum Eligible Age

3 Weeks

Maximum Eligible Age

5 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes