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Prebiotics for Peanut Allergy

Phase 1 & 2

Waitlist Available

Led By Christina E Ciaccio, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Experience dose-limiting symptoms at or before 100mg challenge dose of peanut protein on screening double blind placebo-controlled food challenge (DBPCFC)

Age 4 to 17 (inclusive)

Must not have

Current use of any type of immunotherapy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 4 years

Summary

This trial is testing whether adding a prebiotic to peanut oral immunotherapy is safe and effective. The prebiotic is a type of fiber found in grocery stores, not an FDA-approved drug.

Who is the study for?

This trial is for children aged 4 to 17 with a confirmed peanut allergy, as shown by specific immune markers and reactions in tests. They must have had symptoms at low doses of peanut protein or meet other criteria indicating sensitivity to peanuts. Participants cannot have certain chronic diseases, be on immunomodulatory medications, or be involved in another interventional study.

What is being tested?

The Pinpoint Trial is testing the safety and effectiveness of adding a prebiotic fiber (found in grocery stores) to peanut oral immunotherapy for treating peanut allergies. The study will compare the results of this combination therapy against a placebo alongside standard treatment.

What are the potential side effects?

Potential side effects may include typical allergic reactions due to exposure from the oral immunotherapy such as itching, hives, swelling, gastrointestinal discomfort or more severe reactions like anaphylaxis which would require immediate medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had severe reactions to a small amount of peanut during a test.

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I am between 4 and 17 years old.

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My tests show I'm allergic to peanuts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using immunotherapy.

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I have no history of autoimmune, heart, chronic lung diseases (except asthma), cancer, mental illness, or inflammatory gut conditions.

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I cannot eat fiber supplements, placebo, or peanut flour by mouth for any reason.

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I have severe or uncontrolled asthma.

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I haven't taken any biologic medication or immune system drugs in the last year, except for a short course of oral steroids.

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I have a history of mast cell disease.

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I have undergone oral immunotherapy.

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I have used oral steroids more than once in the past year.

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I am not willing to carry an epinephrine auto-injector.

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I am currently taking oral steroid medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC

Secondary study objectives

The proportion of subjects who experience dose related GI side effects during oral immunotherapy

The proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy

Other study objectives

Change in Peanut skin prick test mean wheal diameter

Change in peanut component levels

Change in peanut specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) levels

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Prebiotic

2016

Completed Phase 2

~800

0 / 13Eligibility criteria met