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Prevention of Cow's Milk Allergy in Children

This study has been completed.
Sponsor:
Collaborator:
Optimed
Information provided by:
Bledina
ClinicalTrials.gov Identifier:
NCT00792090
First received: November 14, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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


Condition Intervention
Milk Hypersensitivity
 Other: Fermented milk
Other: Standard milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Bledina:

Primary Outcome Measures:
  • Sensibilisation and cow's milk allergy [ Time Frame: 4, 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitization or allergy to other allergens [ Time Frame: 4, 12 and 24 months ] [ Designated as safety issue: No ]
  • Atopic diseases (atopic dermatitis, asthma) [ Time Frame: 4, 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: November 2003
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792090

Locations
France
Hôpital central
Nancy, France, 57000
Hôpital Saint Vincent de Paul
Paris, France, 75014
Sponsors and Collaborators
Bledina
Optimed
Investigators
Principal Investigator: Christophe Dupont, PhD Hôpital Saint Vincent de Paul
Principal Investigator: Denise-Anne Moneret-Vautrin, PhD Hôpital central
  More Information

No publications provided

Responsible Party: Valérie BRENAS, Bledina
ClinicalTrials.gov Identifier: NCT00792090     History of Changes
Other Study ID Numbers: BL006
Study First Received: November 14, 2008
Last Updated: November 14, 2008
Health Authority: France: Ministry of Health

Keywords provided by Bledina:
allergy
cow's milk
sensibilisation
fermented milk
infant formula

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 16, 2013