NCT03936998

VE416 for Treatment of Food Allergy

VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Vancomycin plus VE416 before PNOIT	Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT
COMBINATION_PRODUCT	Vancomycin plus VE416 with PNOIT	Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
COMBINATION_PRODUCT	Placebo plus VE416 with PNOIT	Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
COMBINATION_PRODUCT	Placebo plus placebo with PNOIT	Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT

Timeline

• Start date: 2019-06-28
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2019-05-03
• Last updated: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study