VE416 for Treatment of Food Allergy

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03936998
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Wayne G Shreffler, MD, PhD
Phone	617-726-6147
Email	wshreffler@mgh.harvard.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	June 28, 2019
Completion date	January 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05667610` - Immune-supportive Diet and Gut Permeability in Allergic Children	N/A
Recruiting	`NCT05440643` - Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy	Phase 1
Terminated	`NCT03849079` - Validation of the HYPONUT Product	N/A
Completed	`NCT02979600` - Clinical and Biological Efficacy of Peanut Oral Immunotherapy	N/A
Completed	`NCT01955109` - Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children	Phase 2
Completed	`NCT01950533` - The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
Recruiting	`NCT04415593` - High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety	N/A
Active, not recruiting	`NCT04511494` - Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT	N/A
Active, not recruiting	`NCT04887441` - Allergology: Information, Data and Knowledge Organization
Active, not recruiting	`NCT04881773` - Oral Low Doses Tolerance INduction Study for Peanuts
Completed	`NCT03682770` - Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)	Phase 2
Terminated	`NCT03703791` - Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents	Phase 3
Completed	`NCT02916446` - Safety Study of Viaskin Peanut to Treat Peanut Allergy	Phase 3
Active, not recruiting	`NCT02402231` - Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy	Phase 2
Completed	`NCT03337542` - AR101 Real-World Open-Label Extension Study	Phase 3
Recruiting	`NCT05476497` - Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects	Phase 1
Completed	`NCT03648320` - The Grown Up Peanut Immunotherapy Study	N/A
Completed	`NCT03292484` - Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)	Phase 3
Completed	`NCT03852342` - Reactive Doses and Times During Oral Food Challenge to Peanut
Recruiting	`NCT05138757` - Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy	Phase 1/Phase 2