Alpha-gal KO Pork for Alpha-Gal Syndrome
(BeACON4AG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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)
Who Is on the Research Team?
Rachel Robison, M.D.
Principal Investigator
Vanderbilt University Medical Center: Division of Allergy, Pulmonary and Critical Care Medicine
Leonard Bacharier, M.D.
Principal Investigator
Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
Are You a Good Fit for This Trial?
This trial is for people suspected of having alpha-gal syndrome, a type of food allergy to red meat. Participants must be able to safely undergo supervised food challenges and will be screened by the study team for eligibility.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Double Blind Food Challenge (DBFC)
Participants undergo a DBFC to alpha-gal KO pork and WT pork with a minimum 8-day washout period between challenges
Follow-up
Participants are monitored for safety and effectiveness after each food challenge
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares reactions when participants eat two types of pork: one without the alpha-gal sugar (KO pork) and regular pork (WT pork). Each person tries both types on separate days in a double-blind, randomized order.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Each participant will serve as their own control and undergo a DBFC to WT pork, followed by a minimum of a 8-day washout period, then a DBFC to alpha-gal KO pork.
Each participant will serve as their own control and undergo a DBFC to alpha-gal KO pork, followed by a minimum of a 8-day washout period, then a DBFC to WT pork.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Allergy & Asthma Statistical and Clinical Coordinating Center: Rho, Inc
Collaborator
Consortium for Food Allergy Research (CoFAR)
Collaborator
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