Clinical trial NCT05138757: Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
Official title: Fiber Supplementation In Children With Peanut Allergy On Oral Immunotherapy: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peanut Allergy
Keywords: oral immunotherapy
fiber
Peanut
anaphylaxis
allergy
pediatrics
prebiotic
food allergy
microbiome
probiotic
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC
timeFrame: Within 4 years
Secondary outcomes:
measure: The proportion of subjects who experience dose related GI side effects during oral immunotherapy
timeFrame: Within 4 years
measure: The proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy
timeFrame: Within 4 years
Other outcomes:
measure: The effect of a prebiotic on fecal microbiome and metabolome
timeFrame: Within 4 years
measure: Change in peanut specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) levels
timeFrame: Within 4 years
measure: Change in Peanut skin prick test mean wheal diameter
timeFrame: Within 4 years
measure: Change in peanut component levels
timeFrame: Within 4 years
Locations:
city: Chicago
country: United States
facility: Comer Children's Hospital
state: Illinois
city: Hyde Park
country: United States
facility: University of Chicago- Department of Pediatrics
state: Illinois
Study officials:
affiliation: University of Chicago
name: Christina E Ciaccio, MD
role: PRINCIPAL_INVESTIGATOR
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