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

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Allergy; Alpha-Gal Syndrome
• Intervention / Treatment: Diagnostic test: DBFC with 150g of Alpha-gal Knock Out (KO) pork; Diagnostic test: DBFC with 150g of Wild Type (WT) pork

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
      • Contact: Aprile Wicker; Phone Number: 501-364-1998; Email: wickeraj@archildrens.org
      • Principal Investigator: Stacie Jones, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
      • Contact: Morgan Goins; Phone Number: 919-445-7031; Email: morgan_goins@med.unc.edu
      • Principal Investigator: Sarah McGill, MD, MSc
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System: Division of Asthma & Immunology
      • Principal Investigator: Jeffrey Wilson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to understand and provide informed consent and/or have a parent or guardian able to understand and provide informed consent. Participants 12-17 years old must be able to provide assent
2. Participants who are willing to complete study procedures and follow-up
3. Have clinical history consistent with Alpha-gal Syndrome (AGS)
4. Have alpha-gal-specific Immunoglobin E (IgE) >= 0.1KU/L at screening
5. Report reaction consistent with AGS within the previous 24 months (prior to enrollment)
6. If with reproductive potential, agree to be abstinent or use an US Food and Drug Administration (FDA) approved method of birth control for the duration of the study
7. Willing to be trained on the proper use of a device for the self-administration of epinephrine (i.e., autoinjector or intra-nasal spray) and willing to have two doses available for the duration of the study

Exclusion Criteria:

1. Unwilling to consume pork (native/wild type or genetically modified to no longer contain alpha-gal) during Double Blind Food Challenge (DBFC)
2. Have underlying health conditions suggesting that participants should not undergo an oral food challenge, including conditions that may be exacerbated by oral food challenge or treatment with epinephrine (e.g., history of ischemic heart disease, uncontrolled asthma, or cardiac arrhythmia)
3. Likely to move away from the study site prior to completion of follow up or do not have regular access to a phone
4. Have a history of severe anaphylaxis in response to pork or alpha-gal ingestion, defined as neurologic compromise or requiring intubation or cardiovascular compromise defined as myocardial infarction or other clinically significant cardiovascular events
5. Unwilling or unable to stop use of medications that may interfere with oral food challenge interpretation, reaction, or treatment for 5 half-lives prior to the challenge (e.g., antihistamines, beta blockers, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
6. Have used systemic immunomodulators (including biologics and monoclonal antibody therapy) within 6 months before study entry
7. Have underlying health conditions that may increase the chance of false positive challenges (e.g., inflammatory bowel disease, chronic urticaria, systemic mastocytosis, and mast cell activating syndrome)
8. Have used systemic steroids within 4 weeks of study entry
9. Have used any investigational agent within 6 months of study entry
10. Are on build-up of immunotherapy such as Antigen-based Immunotherapy (AIT), Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT), or Epicutaneous Immunotherapy (EPIT)
11. Have reacted to mammalian products with onset of symptoms within 30 minutes of oral ingestion
12. Have current, diagnosed, mental illness or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
13. Are pregnant or plan to become pregnant during the course of the study
14. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, and/or may impact the quality or interpretation of the data obtained from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: DBFC 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 test: DBFC 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
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.	Diagnostic test: DBFC 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 test: DBFC 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Double Blind Food Challenge (DBFC) result to 150 grams of either alpha-gal knockout (KO) pork or wild type (WT) pork.	A positive challenge will be defined as experiencing symptoms grade 2 or higher on the Consortium for Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions (scale range from 1 to 5, with higher scores indicating a more severe reaction) within 6 hours of ingestion.	At Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha-gal sub-phenotype as determined by symptoms resulting from Double Blind Food Challenge (DBFC) to wild-type (WT) pork.	Post-challenge alpha-gal sub-phenotypes as defined by reaction to their first DBFC to WT pork: anaphylaxis, cutaneous-only, or GI-only.	At Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1)
Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) scores in response to 150 grams of Knock Out (KO) or Wild Type (WT) pork at each challenge visit	Validated patient-reported outcome measures: gastrointestinal symptoms based on GSRS-IBS score (score range from 15 to 105, with higher scores indicating a worse outcome).	At 7 days following completion of Double Blind Food Challenge (DBFC) at Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1)
Urticaria Activity Score (UAS7) in response to 150 grams of Knock Out (KO) or Wild Type (WT) pork at each challenge visit.	Validated patient-reported outcome measures: urticaria symptoms based on UAS7 score (score range from 0 to 42, with higher scores indicating a worse outcome).	At 7 days following completion of Double Blind Food Challenge (DBFC) at Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1)

Collaborators and Investigators

• 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
• Investigators: Study Chair: 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

Publications and helpful links

Helpful Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• Consortium of Food Allergy Research (CoFAR)

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2032

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Oral Food Challenge; Alpha-Gal Syndrome
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; red meat allergy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Red Meat; Meat; Pork Meat
• Other Study ID Numbers: DAIT CoFAR-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
• IPD Sharing Time Frame: On average, within 24 months after database lock for the trial.
• IPD Sharing Access Criteria: Open access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No