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Oral Tolerance in Cow's Milk Allergy in the Infant

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Unknown status
CT.gov ID
NCT00298376
Collaborator
(none)
50
Enrollment
1
Location

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    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 :
    Mar 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      1 Month to 15 Months
      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Alain Lachaux Lyon France 69003

      Sponsors and Collaborators

      • Hospices Civils de Lyon

      Investigators

      • Principal Investigator: Alain LACHAUX, MD, Hospices Civils de Lyon

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00298376
      Other Study ID Numbers:
      • 2005.389
      First Posted:
      Mar 2, 2006
      Last Update Posted:
      Apr 27, 2007
      Last Verified:
      Apr 1, 2007
      Keywords provided by , ,
      Cow's milk allergy,
      food allergy
      oral tolerance,
      infant,
      regulatory T cells,
      intestinal microflora
      Additional relevant MeSH terms:
      Hypersensitivity
      Milk Hypersensitivity

      Study Results

      No Results Posted as of Apr 27, 2007