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

4 september 2026 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

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)

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

160

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72202
        • Nog niet aan het werven
        • Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
        • Contact:
        • Hoofdonderzoeker:
          • Stacie Jones, MD
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • Nog niet aan het werven
        • North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
        • Contact:
        • Hoofdonderzoeker:
          • Sarah McGill, MD, MSc
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Werving
        • Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Cosby Stone, Jr, MD, MPH
    • Virginia
      • Charlottesville, Virginia, Verenigde Staten, 22908
        • Nog niet aan het werven
        • University of Virginia Health System: Division of Asthma & Immunology
        • Hoofdonderzoeker:
          • Jeffrey Wilson, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Diagnostische toets: 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
Diagnostische toets: 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
Experimenteel: 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.
Diagnostische toets: 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
Diagnostische toets: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Alpha-gal sub-phenotype as determined by symptoms resulting from Double Blind Food Challenge (DBFC) to wild-type (WT) pork.
Tijdsspanne: At Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1)
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
Tijdsspanne: 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)
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.
Tijdsspanne: 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)
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Medewerkers

Consortium for Food Allergy Research (CoFAR)
Allergy & Asthma Statistical and Clinical Coordinating Center: Rho, Inc

Onderzoekers

  • Studie stoel: Leonard Bacharier, M.D., Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
  • Studie stoel: Rachel Robison, M.D., Vanderbilt University Medical Center: Division of Allergy, Pulmonary and Critical Care Medicine

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 september 2026

Primaire voltooiing (Geschat)

30 oktober 2031

Studie voltooiing (Geschat)

30 oktober 2032

Studieregistratiedata

Eerst ingediend

17 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

4 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DAIT CoFAR-13

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

On average, within 24 months after database lock for the trial.

IPD-toegangscriteria voor delen

Open access.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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