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An Observational Study of Childhood Food Allergy
This study has been completed.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00356174
First received: July 21, 2006
Last updated: September 26, 2016
Last verified: September 2016
| Tracking Information | |||||||
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| First Received Date ICMJE | July 21, 2006 | ||||||
| Last Updated Date | September 26, 2016 | ||||||
| Start Date ICMJE | July 2006 | ||||||
| Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Peanut allergy after the age of three years [ Time Frame: Year 10 ] diagnosed by generally accepted, > 95% accurate, clinical criteria such as oral food challenge. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||
| Change History | Complete list of historical versions of study NCT00356174 on ClinicalTrials.gov Archive Site | ||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | An Observational Study of Childhood Food Allergy | ||||||
| Official Title ICMJE | A Prospective Cohort Study of Immune Mechanisms, Genetic Factors, and Clinical and Environmental Characteristics Associated With the Occurrence and Clinical Outcome of Food Allergy (CoFAR2) | ||||||
| Brief Summary | The purpose of this study is to observe the natural course of food allergy, including both the development of peanut allergy in infants at high risk for developing this allergy, and the resolution of both egg and cow's milk allergy. | ||||||
| Detailed Description | This observational study will investigate the developmental immunology of peanut, egg, and milk allergy in a cohort of milk- or egg-allergic children who are at risk for peanut allergy. This strategy will help to delineate, compare, and contrast biological markers and immunologic changes associated with the development of peanut allergy and loss of egg and milk allergy, while simultaneously evaluating important clinical and environmental influences likely to account for the recent rise in the prevalence of these allergies. The hallmark of food-allergic disease is the production of food-specific Immunoglobulin E (IgE) antibodies that represent an end result of a T helper 2 (Th2) influenced immune response. Currently, there is only a limited understanding of the mechanisms involved in the developmental course of food allergies. To effectively prevent or reverse the progression of food allergy, immune interventions will be needed. Furthermore, it is likely that successful strategies will need to be directed to those persons at identifiable risk (e.g., who have biomarkers associated with development of peanut allergy). | ||||||
| Study Type ICMJE | Observational | ||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples With DNA Description: Buccal swab (DNA) |
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| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Children with milk or egg allergy who are at risk for peanut allergy | ||||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||
| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Enrollment ICMJE | 515 | ||||||
| Completion Date | August 2016 | ||||||
| Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Children with Food Allergy: Participants who meet all of the following criteria are eligible for enrollment as study participants:
Exclusion Criteria for Children with Food Allergy:
Sibling Inclusion Criteria for Mechanistic Studies:
Sibling Exclusion Criteria in Mechanistic Studies:
Sibling Inclusion Criteria for Genetic Testing:
Sibling Exclusion Criteria for Genetic Testing:
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| Sex/Gender |
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| Ages | 3 Months to 15 Months (Child) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00356174 | ||||||
| Other Study ID Numbers ICMJE | DAIT CoFAR2 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | Not Provided | ||||||
| Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
| Collaborators ICMJE | Consortium of Food Allergy Research | ||||||
| Investigators ICMJE |
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| PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
| Verification Date | September 2016 | ||||||
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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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