RecruitingPhase 2NCT07611435

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

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


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

160 participants

Start Date

Sep 15, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 12 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying DBFC with 150g of Alpha-gal Knock Out (KO) pork and DBFC with 150g of Wild Type (WT) pork for people with allergy and alpha-gal syndrome. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDBFC 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_TESTDBFC 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


Locations(4)

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

Little Rock, Arkansas, United States

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

Chapel Hill, North Carolina, United States

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

View Full Details on ClinicalTrials.gov

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NCT07611435


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