Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
Peanut Allergy
About this trial
This is an interventional prevention trial for Peanut Allergy focused on measuring oral immunotherapy, fiber, Peanut, anaphylaxis, allergy, pediatrics, prebiotic, food allergy, microbiome, probiotic
Eligibility Criteria
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 interventional study
- Subject who has undergone any type of oral immunotherapy
- Severe asthma or uncontrolled mild to moderate asthma
- Uncontrolled atopic dermatitis
- Current use of oral steroid medications
- Use of >1 bursts of oral steroid medications in the past year
- Inability to eat by mouth the fiber supplementation or placebo control and peanut flour for any reason
- Use of any therapeutic antibody (biologic medication) or any immunomodulatory medication in the past 12 month (other than a short course of oral steroids)
- Current use of any type of immunotherapy
- Pregnancy or lactation
- Allergy to potato or corn oat or cow's milk
- Unwillingness to carry an epinephrine auto-injector
- Unwillingness to comply with activity restrictions during OIT or any other study procedure
Sites / Locations
- Comer Children's HospitalRecruiting
- University of Chicago- Department of Pediatrics
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment Group
Control Group
Subjects who meet inclusion criteria will be randomized 1:1. The treatment group will receive prebiotic therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the prebiotic. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus prebiotic therapy for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop prebiotic therapy and continue on maintenance POIT in extended observation for approximately 4 years.
Subjects who meet inclusion criteria will be randomized 1:1. The control group will receive placebo therapy for 30 days, then subjects will start peanut oral immunotherapy (POIT) in addition to the placebo. Subjects will continue through a prescribed course of POIT for approximately 180 days. After completion of POIT up-dosing, subjects will continue on maintenance POIT plus placebo for an additional 180 days at which time they will undergo a DBPCFC. Subjects will then stop placebo and continue on maintenance POIT in extended observation for approximately 4 years.