Prebiotic for Peanut Allergy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Peanut AllergyPrebiotic - Drug
Eligibility
4 - 17
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Peanut Allergy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Within 4 years

Within 4 years
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
The effect of a prebiotic on fecal microbiome and metabolome
The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC
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

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Treatment Group
1 of 2
Control Group
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Prebiotic · Has Placebo Group · Phase 1 & 2

Treatment Group
Drug
Experimental Group · 1 Intervention: Prebiotic · Intervention Types: Drug
Control Group
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prebiotic
2016
Completed Phase 2
~630

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 4 years

Who is running the clinical trial?

University of ChicagoLead Sponsor
927 Previous Clinical Trials
753,982 Total Patients Enrolled
Christina E Ciaccio, MDPrincipal InvestigatorUniversity of Chicago

Eligibility Criteria

Age 4 - 17 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a positive skin test to peanut and/or a positive serum IgE to peanut.
You are above the age of 7 years.\n
You have an immune response to peanut proteins.
You have a serum IgE to peanut of at least 0.
You have a positive skin test to peanut and a positive serum IgE to peanut of >5 kUA/L.
You have a history of symptoms consistent with peanut allergy and you have a positive skin prick test to peanut protein.
References