Using alpha-gal KO pork to see if it reduces reactions in people with Alpha-gal Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, controlled crossover trial in individuals with Alpha-gal Syndrome. Participants receive 150 g portions of alpha-gal Knock Out pork and 150 g portions of Wild Type pork on different days, with at least an 8-day washout between challenges. Each participant serves as their own control to compare the likelihood of a positive oral food challenge between KO and WT pork. The primary goal is to see if KO pork reduces positive reactions compared with WT pork during double-blind food challenges. The study characterizes participants by clinical sub-phenotypes of AGS and requires informed consent, age-appropriate assent, and readiness to manage epinephrine administration if needed.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
  Nashville, Tennessee, United States Recruiting
• Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
  Little Rock, Arkansas, United States Not yet recruiting
• North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
  Chapel Hill, North Carolina, United States Not yet recruiting
• University of Virginia Health System: Division of Asthma & Immunology
  Charlottesville, Virginia, United States Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.