Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
United States20 participantsStarted 2021-11-30
Plain-language summary
The purpose of this research is to gather information on the safety and efficacy of using a prebiotic as an adjunctive therapy to peanut oral immunotherapy. The prebiotic is not an FDA approved drug or medication rather a fiber found at local grocery stores.
Who can participate
Age range4 Years – 17 Years
SexALL
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Inclusion Criteria:
* Age 4 to 17 (inclusive)
* A convincing clinical history of peanut allergy
* Immune markers consistent with peanut allergy
* Serum IgE to peanut of \>0.35 kUA/L and a skin prick test to peanut \>8mm greater than the negative saline control -or-
* Serum IgE to peanut of \>5 kUA/L and a mean peanut wheal diameter on skin prick test 3 to 8mm greater than the negative saline control -or-
* Serum IgE to peanut of \>14 kUA/L and mean peanut wheal diameter on skin prick test 3mm greater than the negative saline control
* Experience dose-limiting symptoms at or before 100mg challenge dose of peanut protein on screening double blind placebo-controlled food challenge (DBPCFC)
* Written informed consent from parent/guardian
* Written assent from subjects above the age of 7
Exclusion Criteria:
* • History of a chronic disease (other than asthma, allergic rhinitis, and atopic dermatitis) that is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen
* History of mast cell disease
* History of recurrent idiopathic or virally induced urticaria, angioedema or anaphylaxis
* Any history or presence of autoimmune, cardiovascular disease, chronic lung disease (other than asthma), malignancy, psychiatric illness, or gastrointestinal inflammatory conditions, including celiac disease, inflammatory bowel disease, eosinophilic esophagitis or other eosinophilic gastrointestinal disease
* Current participation in any other i…
What they're measuring
1
The Proportion of Subjects Mildly Symptomatic or Less at the 12 Month DBPCFC
Timeframe: At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).