CLINICAL TRIAL / NCT05138757

Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

Interventional
Recruiting
NCT05138757

Eligibility Details Visit Clinicaltrials.gov

Contact Information

Fiber Supplementation In Children With Peanut Allergy On Oral Immunotherapy: A Randomized Controlled Pilot Study

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.

Detailed Description

By doing this study, we hope to learn if using a dietary fiber called a "prebiotic" helps increase the number of children who can tolerate eating 1043mg of peanut protein (or about 3-4 peanuts) after going through oral immunotherapy (OIT) to peanut. We are also trying to determine if this fiber will reduce the side effects of OIT and if so, we would like to find out if the reason it is working is by changing the bacteria in the gut. Participation in this research will last about five years.

Eligibility Details

Gender
All

Age Group
4 Years to 17 Years

Accepting Healthy Volunteers
No

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: - â€¢ 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