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Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG

NCT07611435 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-28

No results posted yet for this study

Summary

This is a multisite, randomized, double-blind, controlled cross-over trial with detailed characterization of participants with varying clinical sub-phenotypes of Alpha-gal Syndrome (AGS) who are then evaluated by oral food challenges with alpha-gal Knock Out (KO) pork versus Wild Type (WT) pork. Each participant will serve as their own control and ingest both alpha-gal-KO and WT pork on different days, with a minimum of an 8-day washout period between oral food challenges.

The primary objective is to determine whether the odds of positive challenges among participants with suspected alpha-gal syndrome are lower with alpha-gal Knock Out (KO) pork as compared to Wild Type (WT) pork during Double Blind Food Challenge (DBFC)

Conditions

  • Alpha-Gal Syndrome
  • Allergy

Interventions

DIAGNOSTIC_TEST

DBFC with 150g of Alpha-gal Knock Out (KO) pork

Each participant will serve as their own control and ingest both alpha-gal-KO and WT pork on different days, with a minimum of an 8-day washout period between oral food challenges

DIAGNOSTIC_TEST

DBFC with 150g of Wild Type (WT) pork

Each participant will serve as their own control and ingest both alpha-gal-KO and WT pork on different days, with a minimum of an 8-day washout period between oral food challenges

Sponsors & Collaborators

  • Consortium for Food Allergy Research (CoFAR)

    collaborator UNKNOWN

  • Allergy & Asthma Statistical and Clinical Coordinating Center: Rho, Inc

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Leonard Bacharier, M.D. · Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine

  • Rachel Robison, M.D. · Vanderbilt University Medical Center: Division of Allergy, Pulmonary and Critical Care Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2031-09-30
Completion
2032-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07611435 on ClinicalTrials.gov