Prevention of Cow's Milk Allergy in Children

NCT ID: NCT00792090

Last Updated: 2008-11-17

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

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-07-31

Brief Summary

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Impact of fermented milk in prevention of cow's milk allergy in new born and infants

Detailed Description

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Conditions

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Milk Hypersensitivity

Keywords

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allergy cow's milk sensibilisation fermented milk infant formula

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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1

Fermented milk

Group Type EXPERIMENTAL

Fermented milk

Intervention Type OTHER

Formula used for non breastfed children or in complement of breastfeeding

2

Standard milk

Group Type ACTIVE_COMPARATOR

Standard milk

Intervention Type OTHER

Formula used for non breastfed children or in complement of breastfeeding

Interventions

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Fermented milk

Formula used for non breastfed children or in complement of breastfeeding

Intervention Type OTHER

Standard milk

Formula used for non breastfed children or in complement of breastfeeding

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* mother before the 5th month of pregnancy
* mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
* mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
* atopic mother or father and at least another atopic member (sister or brother)
* parents having given written informed consent
* adhesion to eviction regimen for mother and child
* parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)

Exclusion Criteria

* mother in an exclusion period from another study
* parents refusing to sign the informed consent
* infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator
* known or suspected immunodeficiency in the family
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Optimed Medizinische Instrumente GmbH

INDUSTRY

Sponsor Role collaborator

Bledina

INDUSTRY

Sponsor Role lead

Responsible Party

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Bledina

Principal Investigators

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Christophe Dupont, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Vincent de Paul

Denise-Anne Moneret-Vautrin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital central

Locations

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Hôpital central

Nancy, , France

Site Status

Hôpital Saint Vincent de Paul

Paris, , France

Site Status

Countries

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France

Other Identifiers

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BL006

Identifier Type: -

Identifier Source: org_study_id