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

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)

NCT Number	NCT07611435
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID) Collaborators: Consortium for Food Allergy Research (CoFAR), Allergy & Asthma Statistical and Clinical Coordinating Center: Rho, Inc
Conditions	Alpha-Gal Syndrome, Allergy
Enrollment	160 participants
Start Date	2026-07-30
Primary Completion	2031-09-30 (estimated)
Study Completion	2032-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-06