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
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
First received: March 1, 2006
Last updated: April 26, 2007
Last verified: April 2007

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.

Cow’s Milk Allergy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal
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:

Further study details as provided by Hospices Civils de Lyon:

Estimated Enrollment: 50
Study Start Date: March 2006

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

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

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

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
Principal Investigator: Alain LACHAUX, MD Hospices Civils de Lyon
  More Information

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,
regulatory T cells,
intestinal microflora

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

ClinicalTrials.gov processed this record on May 26, 2016