Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-25 @ 4:04 PM
Study NCT ID:
NCT05138757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2021-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
Fiber Supplementation In Children With Peanut Allergy On Oral Immunotherapy: A Randomized Controlled Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: