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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07611435
Phase
PHASE2
Status
Recruiting
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Conditions

  • Allergy
  • Alpha-Gal Syndrome

Eligibility Criteria

Sex
ALL
Age
12 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • DBFC with 150g of Alpha-gal Knock Out (KO) pork — DIAGNOSTIC_TEST
    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
  • DBFC with 150g of Wild Type (WT) pork — DIAGNOSTIC_TEST
    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

Study Details

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)

Key Dates

First listed
May 28, 2026
Start date
Sep 15, 2026
Status verified
Sep 2026
Primary completion
Oct 30, 2031
Completion
Oct 30, 2032

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Sequence 1: KO, then WT
    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.
  • Experimental: Sequence 2: WT, then KO
    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.

Primary Outcome Measure

Positive Double Blind Food Challenge (DBFC) result to 150 grams of either alpha-gal knockout (KO) pork or wild type (WT) pork. [ Time Frame: At Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & ImmunologyLittle RockArkansas72202
Aprile Wicker
[email protected]
501-364-1998
Stacie Jones, MD (PRINCIPAL_INVESTIGATOR)
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and RheumatologyChapel HillNorth Carolina27599
Morgan Goins
[email protected]
919-445-7031
Sarah McGill, MD, MSc (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary MedicineNashvilleTennessee37232
Theresa Rogers
[email protected]
615-343-1277
Cosby Stone, Jr, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Virginia Health System: Division of Asthma & ImmunologyCharlottesvilleVirginia22908
Jeffrey Wilson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology· Little Rock, ARNorth Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology· Chapel Hill, NCVanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine· Nashville, TNUniversity of Virginia Health System: Division of Asthma & Immunology· Charlottesville, VA

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