Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    30
  • sponsor
    University of Chicago
Updated on 13 March 2022

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.

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.

Details
Condition Peanut Allergy
Treatment Placebo, Prebiotic
Clinical Study IdentifierNCT05138757
SponsorUniversity of Chicago
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
Written informed consent from parent/guardian
on screening double blind placebo-controlled food challenge (DBPCFC)
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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