Accepts Healthy Volunteers
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 Years - 14 Years|
Inclusion Criteria:-Subject and/or parent guardian must be able to understand and provide informed consent. Inclusion criteria for screening DBPCFC:
- - Age 4-14 years.
- - either sex.
- - any race, any ethnicity.
- - who are enrolled while strictly avoiding peanut.
- - have a history of sensitization (detectable peanut IgE >0.35 kUA/L) Inclusion criteria for randomization: - On screening DBPCFC are able to ingest >= 143 mg peanut protein but < 5043 mg peanut protein.
- - All children will have documented consent and assent as is appropriate for age.
Exclusion Criteria:Individuals who meet any of these criteria are not eligible for enrollment as study participants:
- - Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- - Serum peanut-specific IgE antibody level > 50 kUA/L.
- - Recent (within the past 2 years) life-threatening (grade 3) anaphylactic reaction to peanut.
- - Any disorder in which epinephrine is contraindicated such as known hypertension or cardia rhythm disorders.
- - History of chronic disease requiring therapy (other than asthma, atopic dermatitis, rhinitis).
- - On a build-up phase of any allergen immunotherapy.
- - For those with a history of asthma, the following are assessed and any of the following is an exclusion (markers of current uncontrolled or moderate to severe asthma): 1.
- - Gastrointestinal eosinophilic disorders, esophagitis, gastroenteritis.
- - Use of short-acting antihistamines (diphenhydramine, etc.) more than one time within 3 days prior to DBPCFC or skin testing.
- - Use of medium-acting antihistamines (hydroxyzine, loratadine, etc.) more than one time within 7 days of DBPCFC or skin testing.
- - Use of systemic steroid medications (IV, IM or oral) for indications other than asthma for > 3 weeks within the past 6 months.
- - Use of beta-blockers (oral), (ACE) inhibitors, angiotensin-receptor blockers or calcium channel blockers.
- - Participation in any trials of therapeutic interventions for food allergy in the past year.
- - Therapy with anti-IgE or other biologics, including within 1 year of enrollment.
- - Use of investigational drugs within 52 weeks of participation.
- - Allergy to all of the following: oat, rice, corn, tapioca.
- - Pregnancy.
- - Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Scott Sicherer, MD|
|Principal Investigator Affiliation||Icahn School of Medicine at Mount Sinai|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Food Allergy, Peanut Allergy|
Active Comparator: Treatment
Ingests peanut - . Depending upon reaction threshold, participants may begin with different starting amounts of store bought peanut butter measured with study-supplied kitchen measuring spoons.
No Intervention: Avoidance
Avoids peanut, standard care
Biological: - Peanut Protein
up to 9043 mg
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.