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Oral Tolerance in Cow’s Milk Allergy in the Infant

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298376
First Posted: March 2, 2006
Last Update Posted: April 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospices Civils de Lyon
  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:


Further study details as provided by Hospices Civils de Lyon:

Estimated Enrollment: 50
Study Start Date: March 2006
  Eligibility

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
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
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


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

ClinicalTrials.gov Identifier: NCT00298376     History of Changes
Other Study ID Numbers: 2005.389
First Submitted: March 1, 2006
First Posted: March 2, 2006
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,
infant,
regulatory T cells,
intestinal microflora

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