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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 1, 2006 | ||||||||
| Last Updated Date | April 26, 2007 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00298376 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Oral Tolerance in Cow’s Milk Allergy in the Infant | ||||||||
| Official Title ICMJE | Oral Tolerance in Cow’s Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Natural History, Longitudinal, Case Control, Prospective Study | ||||||||
| Condition ICMJE | Cow’s Milk Allergy | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||||||
| Ages | 1 Month to 15 Months | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00298376 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 2005.389 | ||||||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Hospices Civils de Lyon | ||||||||
| Verification Date | April 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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