An observational study in Food Hypersensitivity, Peanut Hypersensitivity and Egg Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 5 sites in United States. Open to participants aged 3 Months to 15 Months. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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).
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's enrollment of 515 is above the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with milk or egg allergy who are at risk for peanut allergy
Inclusion Criteria for Children with Food Allergy: Participants who meet all of the following criteria are eligible for enrollment as study participants:
Either
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
340 longitudinally followed children with egg and/or milk allergy without elevated peanut specific Immunoglobulin E (IgE), less than 5 kUA/L
Approximately 250 not age matched full siblings (i.e., non-step siblings, non-half siblings) will be recruited as an additional control group for genetic studies.
Approximately 50 not age matched full siblings (i.e., non-step siblings, non-half siblings) will be recruited as an additional control group for mechanistic studies. A subset of this cohort will be without food allergy,
Peanut allergy after the age of three years
diagnosed by generally accepted, \> 95% accurate, clinical criteria such as oral food challenge.
Time frame: Year 10
Resolution of milk allergy after the age of three years
determined by well established criteria with \> 95% diagnostic accuracy. Additional (interval analysis) endpoints of egg and milk allergy will be explored in younger children because these allergies may resolve earlier. Common clinical allergy evaluations (e.g., prick skin tests and food-specific IgE antibodies to the 3 targeted foods and common environmental allergens) will be performed and incorporated in the diagnoses of food allergy and atopy.
Time frame: Year 10
Resolution of egg allergy after the age of three years
determined by well established criteria with \> 95% diagnostic accuracy.
Time frame: Year 10
Resolution of peanut allergy after the age of three years
determined by well established criteria with \> 95% diagnostic accuracy.
Time frame: Year 10
Resolution of a positive test to peanut after the age of three years (suspected allergy category)
determined by well established criteria with \> 95% diagnostic accuracy.
Time frame: Year 10
Development/persistence of milk allergy after the age of three years
determined by well established criteria with \> 95% diagnostic accuracy.
Time frame: Year 10
Development/persistence of egg allergy
determined by well established criteria with \> 95% diagnostic accuracy.
Time frame: Year 10
The record gives a start of Jul 2006, a primary completion of Aug 2015 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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