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Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

Primary Purpose

Peanut Allergy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prebiotic
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peanut Allergy focused on measuring oral immunotherapy, fiber, Peanut, anaphylaxis, allergy, pediatrics, prebiotic, food allergy, microbiome, probiotic

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comer Children's HospitalRecruiting
  • University of Chicago- Department of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC
To determine the proportion of subjects who tolerate at least 1043 mg cumulative of peanut protein with no more than mild symptoms at the 12 month DBPCFC

Secondary Outcome Measures

The proportion of subjects who experience dose related GI side effects during oral immunotherapy
• To determine 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
• To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy

Full Information

First Posted
October 22, 2021
Last Updated
March 1, 2022
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05138757
Brief Title
Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
Official Title
Fiber Supplementation In Children With Peanut Allergy On Oral Immunotherapy: A Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
oral immunotherapy, fiber, Peanut, anaphylaxis, allergy, pediatrics, prebiotic, food allergy, microbiome, probiotic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prebiotic
Intervention Description
A prebiotic is a purified fiber of plant origin that has digestive health benefits by fostering the growth of beneficial microbes.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A placebo is a substance that has no therapeutic effects used as a control while testing new drugs.
Primary Outcome Measure Information:
Title
The proportion of subjects mildly symptomatic or less at the 12 month DBPCFC
Description
To determine the proportion of subjects who tolerate at least 1043 mg cumulative of peanut protein with no more than mild symptoms at the 12 month DBPCFC
Time Frame
Within 4 years
Secondary Outcome Measure Information:
Title
The proportion of subjects who experience dose related GI side effects during oral immunotherapy
Description
• To determine the proportion of subjects who experience dose related GI side effects during oral immunotherapy.
Time Frame
Within 4 years
Title
The proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy
Description
• To determine the proportion of subjects who experience hypersensitivity reactions (other than GI) during oral immunotherapy
Time Frame
Within 4 years
Other Pre-specified Outcome Measures:
Title
The effect of a prebiotic on fecal microbiome and metabolome
Description
To demonstrate the effect of a prebiotic on the fecal microbiome and metabolome To determine if gnotobiotic mice colonized with the fecal microbiota of study participants models clinical response
Time Frame
Within 4 years
Title
Change in peanut specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) levels
Description
• To determine if a change exists in peanut specific Immunoglobulin E (IgE) and Immunoglobulin G4 (IgG4) levels
Time Frame
Within 4 years
Title
Change in Peanut skin prick test mean wheal diameter
Description
• To determine if a change exists in peanut skin prick test mean wheal diameter
Time Frame
Within 4 years
Title
Change in peanut component levels
Description
• To determine if a change exists in peanut component levels
Time Frame
Within 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina E Ciaccio, MD
Phone
773.834.4010
Email
cciaccio@bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jamel I Mansur, MD
Phone
773.702.0943
Email
jmansur7@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina E Ciaccio, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina E Ciaccio, MD
Phone
773-834-4010
Email
cciaccio@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Jamel I Mansur, MD
Phone
773.702.1220
Ext
44343
Email
jmansur7@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Jamel I Mansur, MD
First Name & Middle Initial & Last Name & Degree
Steve Handoyo, MD
First Name & Middle Initial & Last Name & Degree
Ruchi Singla, MD
First Name & Middle Initial & Last Name & Degree
Brittany Graff, NP
Facility Name
University of Chicago- Department of Pediatrics
City
Hyde Park
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Puplava, MS
Phone
773-702-2879
Email
rpuplava@peds.bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided: It is not yet known if there will be a plan to make IPD available.
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Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

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