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Clinical trialNCT07611435Not, yet, recruitingPhase 2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment160AllergyAlpha-Gal Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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)

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Leonard Bacharier, M.D.

    Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine

    Study Chair
  • Rachel Robison, M.D.

    Vanderbilt University Medical Center: Division of Allergy, Pulmonary and Critical Care Medicine

    Study Chair

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Arkansas Children'S Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

    Little Rock, Arkansas, United States

    Stacie Jones, MD
  • North Carolina Children'S Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

    Chapel Hill, North Carolina, United States

    Sarah McGill, MD, MSc
  • Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine

    Nashville, Tennessee, United States

  • University of Virginia Health System: Division of Asthma & Immunology

    Charlottesville, Virginia, United States

    Jeffrey Wilson, MD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jul 2026
Primary completion
30 Sept 2031
Completion
30 Sept 2032
Last update posted
6 Jul 2026
Registered enrollment
160
Registry id
NCT07611435

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.