Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Drug: Prebiotic
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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. | Drug: Prebiotic<br>* A prebiotic is a purified fiber of plant origin that has digestive health benefits by fostering the growth of beneficial microbes.<br>|
| Placebo Comparator: Control Group<br>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. | Drug: Placebo<br>* A placebo is a substance that has no therapeutic effects used as a control while testing new drugs.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC | To determine the proportion of subjects who tolerate at least 1043 mg cumulative of peanut protein with no more than mild symptoms at the 12 month DBPCFC | Within 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who experience dose related GI side effects during oral immunotherapy | • To determine the proportion of subjects who experience dose related GI side effects during oral immunotherapy. | Within 4 years | 
| The proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy | • To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy | Within 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral immunotherapy, Peanut, anaphylaxis, allergy, pediatrics, prebiotic, food allergy, microbiome, probiotic, fiber