Prevention of Cow's Milk Allergy in Children

November 14, 2008 updated by: Bledina

Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 57000
        • Hôpital Central
      • Paris, France, 75014
        • Hôpital Saint Vincent de Paul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Fermented milk
Other: Fermented milk
Formula used for non breastfed children or in complement of breastfeeding
ACTIVE_COMPARATOR: 2
Standard milk
Other: Standard milk
Formula used for non breastfed children or in complement of breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensibilisation and cow's milk allergy
Time Frame: 4, 12 and 24 months
4, 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitization or allergy to other allergens
Time Frame: 4, 12 and 24 months
4, 12 and 24 months
Atopic diseases (atopic dermatitis, asthma)
Time Frame: 4, 12 and 24 months
4, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bledina

Collaborators

Optimed Medizinische Instrumente GmbH

Investigators

  • Principal Investigator: Denise-Anne Moneret-Vautrin, PhD, Hôpital Central

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (ESTIMATE)

November 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 17, 2008

Last Update Submitted That Met QC Criteria

November 14, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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