NCT05138757

Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

Fiber Supplementation In Children With Peanut Allergy On Oral Immunotherapy: A Randomized Controlled Pilot Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	Prebiotic	A prebiotic is a purified fiber of plant origin that has digestive health benefits by fostering the growth of beneficial microbes.
DRUG	Placebo	A placebo is a substance that has no therapeutic effects used as a control while testing new drugs.

Timeline

• Start date: 2021-11-30
• Primary completion: 2025-03-12
• Completion: 2025-03-12
• First posted: 2021-12-01
• Last updated: 2026-03-09
• Results posted: 2026-03-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study