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Oral Tolerance in Cow’s Milk Allergy in the Infant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00298376
First received: March 1, 2006
Last updated: April 26, 2007
Last verified: April 2007
History of Changes
  Purpose

This study aims to determine if there is a link between cow’s milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others.

Cow’s milk allergy is evaluated by basophils activation test, T cells activation test, specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month avoiding food, before and after low dose milk exposure, before and after oral challenge.

Number and function of regulatory T cells and microflora composition are measured at the same time.

Allergic infants are compared to age matched control group.


Condition
Cow’s Milk Allergy

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Oral Tolerance in Cow’s Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Estimated Enrollment: 50
Study Start Date: March 2006
  Eligibility

Ages Eligible for Study:   1 Month to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

male or female, age before 6 month, cow’s milk allergy with positive prick or patch test for cow’s milk

Control group: male or female, age before 6 month or within 12 and 18 month, eating cow’s milk every day

Exclusion Criteria:

immunodeficiency syndrome, lactose intolerance Control group: other food allergy, atopic dermatitis.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298376

Contacts
Contact: Florence VILLARD-TRUC, MD 33 472 110 390 fvillardtruc@hotmail.com
Contact: Dominique KAISERLIAN, PhD kaiserlian@cervi-lyon.inserm.fr

Locations
France
Alain Lachaux Recruiting
Lyon, France, 69003
Contact: Alain LACHAUX, MD     33 472 110 390     alain.lachaux@chu-lyon.fr    
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Alain LACHAUX, MD Hospices Civils de Lyon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298376     History of Changes
Other Study ID Numbers: 2005.389
Study First Received: March 1, 2006
Last Updated: April 26, 2007
Health Authority: France: Ministry of Health

Keywords provided by Hospices Civils de Lyon:
Cow’s milk allergy,
food allergy
oral tolerance,
 infant,
regulatory T cells,
intestinal microflora

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

ClinicalTrials.gov processed this record on May 19, 2013