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Prebiotics for Peanut Allergy

Phase 1 & 2
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC
Secondary outcome measures
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 outcome measures
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
~720

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,668 Total Patients Enrolled
Christina E Ciaccio, MDPrincipal InvestigatorUniversity of Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study allow for participants who are older than 25 years of age?

"To be eligible for this clinical trial, applicants must be aged 4 to 17. Out of the 248 total studies, 86 are geared towards children while 162 are for adults over 65."

Answered by AI

Are we still able to include new test subjects in this research?

"The clinical trial is recruiting patients, with the most recent update to the posting on clinicaltrials.gov being on March 1st, 2022. The study was originally posted on November 30th, 2021."

Answered by AI

Who can sign up for this experiment?

"This clinical trial is enrolling 30 participants with peanut allergies aged 4 and 17. Most notable, patients should meet the following criteria: -Age 4 to 17 (inclusive)-A convincing clinical history of peanut allergy -Serum IgE to peanut of >14 kUA/L and mean peanut wheal diameter on skin prick test 3mm greater than the negative saline control -Written informed consent from parent/guardian -Written assent from subjects above the age of 7 -Immune markers consistent with peanut allergy (-or-) -Serum IgE to peanut"

Answered by AI

How many people have signed up for this experiment so far?

"That is correct. According to the information available on clinicaltrials.gov, this trial posted on 11/30/2021 and edited on 3/1/2022 is still recruiting patients. They are looking for 30 individuals to participate at 2 locations."

Answered by AI
Recent research and studies
~10 spots leftby Jun 2025