Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

The University of Chicago

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Peanut Allergy

Treatments: Drug: Prebiotic; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05138757

IRB21-0589

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

30 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

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.

Treatment:

Drug: Prebiotic

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo