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

NCT07611435 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DAIT CoFAR-13
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief 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)

Conditions

Alpha-Gal Syndrome; Allergy

Keywords

Alpha-Gal Syndrome; Oral Food Challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Alpha-gal sub-phenotype as determined by symptoms resulting from Double Blind Food Challenge (DBFC) to wild-type (WT) pork.

  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

  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.

  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)

Study Arms (2)

Sequence 1: KO, then WT

EXPERIMENTAL

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; Diagnostic Test: DBFC with 150g of Wild Type (WT) pork

Sequence 2: WT, then KO

EXPERIMENTAL

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; Diagnostic Test: DBFC with 150g of Wild Type (WT) pork

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

Sequence 1: KO, then WT; Sequence 2: WT, then KO

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

Sequence 1: KO, then WT; Sequence 2: WT, then KO

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Participants who are willing to complete study procedures and follow-up
• Have clinical history consistent with Alpha-gal Syndrome (AGS)
• Have alpha-gal-specific Immunoglobin E (IgE) \>= 0.1KU/L at screening
• Report reaction consistent with AGS within the previous 24 months (prior to enrollment)
• 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
• 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

You may not qualify if:

• Unwilling to consume pork (native/wild type or genetically modified to no longer contain alpha-gal) during Double Blind Food Challenge (DBFC)
• 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)
• Likely to move away from the study site prior to completion of follow up or do not have regular access to a phone
• 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
• 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)
• Have used systemic immunomodulators (including biologics and monoclonal antibody therapy) within 6 months before study entry
• 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)
• Have used systemic steroids within 4 weeks of study entry
• Have used any investigational agent within 6 months of study entry
• Are on build-up of immunotherapy such as Antigen-based Immunotherapy (AIT), Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT), or Epicutaneous Immunotherapy (EPIT)
• Have reacted to mammalian products with onset of symptoms within 30 minutes of oral ingestion
• 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
• Are pregnant or plan to become pregnant during the course of the study
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Consortium for Food Allergy Research (CoFAR): collaborator
• Allergy & Asthma Statistical and Clinical Coordinating Center: Rho, Inc: collaborator

Study Sites (4)

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

Little Rock, Arkansas, 72202, United States

Location

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

Chapel Hill, North Carolina, 27599, United States

Location

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

Nashville, Tennessee, 37232, United States

Location

University of Virginia Health System: Division of Asthma & Immunology

Charlottesville, Virginia, 22908, United States

Location

Related Links

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

MeSH Terms

Conditions

red meat allergy; Hypersensitivity

Interventions

Pork Meat

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Red Meat; Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 28, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2032
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: On average, within 24 months after database lock for the trial.
• Access Criteria: Open access.

Locations

US (4)