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Early Peanut Introduction: Translation to Clinical Practice
The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is a major step towards prevention of food allergy. However, because that finding was from a clinical trial in a very select population, there are several major questions that must be answered in order to implement these findings into clinical practice without causing more harm than good. These questions include who, if anyone, should be screened prior to early introduction for peanut allergy, how this screening should be done, and what quantity of peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer these critical questions so that the potential of these recent findings can be realized. To that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut IgE, and then will be followed for assessment of peanut consumption and development of peanut allergy until 3 years of age.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||4 Months - 11 Months|
- - Infants age 4-11 months - Have at least one of the following criteria: 1.
Exclusion Criteria:- History of feeding problems - History of eosinophilic gastro-intestinal disease - Significant medical history (aside from eczema, food allergy or history of wheeze) - History of peanut reactions or tolerance prior to baseline screening
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Johns Hopkins University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Corinne Keet, MD|
|Principal Investigator Affiliation||Johns Hopkins University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective observational study. All subjects will have a baseline research clinic visit, where they will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants will be advised to begin introducing peanut following the current practice guidelines. Participants will then be followed until 30 months of age with two clinic visits and regular monitoring of peanut consumption.
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