Cow’s Milk Allergy Clinical Trial
Official title:
Oral Tolerance in Cow’s Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora
| NCT number | NCT00298376 |
| Other study ID # | 2005.389 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | March 1, 2006 |
| Last updated | April 26, 2007 |
| Start date | March 2006 |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 1 Month to 15 Months |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Longitudinal
| Country | Name | City | State |
|---|---|---|---|
| France | Alain Lachaux | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,