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Oral Tolerance in Cow’s Milk Allergy in the Infant

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ClinicalTrials.gov Identifier: NCT00298376
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : March 2, 2006
Last Update Posted : April 27, 2007
Information provided by:
Hospices Civils de Lyon

Brief Summary:

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 or disease
Cow’s Milk Allergy

Study Type : Observational
Estimated Enrollment : 50 participants
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
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 15 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00298376     History of Changes
Other Study ID Numbers: 2005.389
First Posted: March 2, 2006    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

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
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate