Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

February 16, 2026 updated by: University of Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Comer Children's Hospital
      • Hyde Park, Illinois, United States, 60637
        • University of Chicago- Department of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

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
Time Frame: At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
To determine the proportion of subjects who met the primary endpoint by tolerating at least 2044 mg cumulative peanut protein with no more than mild symptoms during the 12-month DBPCFC.
At the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects Who Experience Dose Related GI Side Effects During Oral Immunotherapy
Time Frame: From first study intervention through the final exit food challenge visit, up to 15 months.
• To determine the proportion of subjects who experience dose related GI side effects during oral immunotherapy.
From first study intervention through the final exit food challenge visit, up to 15 months.
The Proportion of Subjects Who Experience Hypersensitivity Reactions (Other Than GI) During Oral Immunotherapy
Time Frame: From first study intervention through the final exit food challenge visit, up to 15 months.
• To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy
From first study intervention through the final exit food challenge visit, up to 15 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal Butyrate Concentration (mM)
Time Frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
Fecal samples were collected at each study time point and analyzed for butyrate concentration using metabolomic profiling. Results are reported in millimolar (mM).
At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
Change in Peanut Specific Immunoglobulin E (IgE) Levels
Time Frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
• To determine if a change exists in peanut specific Immunoglobulin E (IgE) levels
At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
Change in Peanut Specific Immunoglobulin G4 (IgG4) Levels
Time Frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
• To determine if a change exists in peanut specific Immunoglobulin G4 (IgG4) levels
At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
Change in Peanut Skin Prick Test Mean Wheal Diameter
Time Frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
• To determine if a change exists in peanut skin prick test mean wheal diameter
At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
Change in Peanut Component Levels
Time Frame: At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).
• To determine if a change exists in peanut component levels (peanut Ara h 2)
At baseline; after 1 month of fiber/placebo; and at the exit double-blind placebo-controlled food challenge (approximately 13 months after enrollment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Christina E Ciaccio, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Actual)

March 12, 2025

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB21-0589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Undecided: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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