An Observational Study of Childhood Food Allergy
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ClinicalTrials.gov Identifier: NCT00356174 |
Recruitment Status
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Completed
First Posted
: July 25, 2006
Last Update Posted
: September 28, 2016
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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)
Tracking Information | |||||||
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First Submitted Date | July 21, 2006 | ||||||
First Posted Date | July 25, 2006 | ||||||
Last Update Posted Date | September 28, 2016 | ||||||
Study Start Date | July 2006 | ||||||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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 | Not Provided | ||||||
Change History | Complete list of historical versions of study NCT00356174 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Outcome Measures | Not Provided | ||||||
Original Other Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | An Observational Study of Childhood Food Allergy | ||||||
Official Title | 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 | Observational | ||||||
Study Design | 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 |
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Intervention | 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 | Completed | ||||||
Actual Enrollment |
515 | ||||||
Original Enrollment |
650 | ||||||
Actual Study Completion Date | August 2016 | ||||||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | 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 | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT00356174 | ||||||
Other Study ID Numbers | DAIT CoFAR2 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Study Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Collaborators | Consortium of Food Allergy Research | ||||||
Investigators |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||
Verification Date | September 2016 |