NCT00298376

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

March 1, 2006

Last Update Submit

April 26, 2007

Conditions

Cow's Milk Allergy

Keywords

Cow's milk allergy,food allergyoral tolerance,infant,regulatory T cells,intestinal microflora

Eligibility Criteria

Age1 Month - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alain Lachaux

Lyon, 69003, France

RECRUITING

MeSH Terms

Conditions

Milk HypersensitivityFood Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Alain LACHAUX, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence VILLARD-TRUC, MD

CONTACT

33 472 110 390fvillardtruc@hotmail.com

Dominique KAISERLIAN, PhD

CONTACT

kaiserlian@cervi-lyon.inserm.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 2, 2006

Study Start

March 1, 2006

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

FR(1)