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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014