VE416 for Treatment of Food Allergy
VE416 for Treatment of Food Allergy
Brief Summary:
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
Detailed Description:
In this research study the investigators want to learn more about an investigational medicine called VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy. VE416 is a combination of dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines and in combination with peanut flour may help to prevent participants from getting sick (upset stomach, breathing problems, and skin problems) when participants come into contact with peanuts.
The investigators are doing this research study to find out if VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy can help people with peanut allergy. VE416 is a consortium of commensal, or "friendly", dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines. The investigators also want to find out if VE416 with peanut oral immunotherapy is safe to take without causing too many side effects.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy
Actual Study Start Date: June 28, 2019
Estimated Primary Completion Date: December 1, 2021
Estimated Study Completion Date: December 1, 2022
Arm:
- Experimental: vancomycin plus VE416 before PNOIT
- Experimental: Vancomycin plus VE416 with PNOIT
- Experimental: Placebo plus VE416 with PNOIT
- Active Comparator: Placebo plus placebo with PNOIT
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 60 |
| Estimated Study start date | 28 June 2019 |
| Estimated Study Completion Date | 01 December 2022 |