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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 uppdaterad av: 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)

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

160

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72202
        • Har inte rekryterat ännu
        • Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
        • Kontakt:
        • Huvudutredare:
          • Stacie Jones, MD
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • Har inte rekryterat ännu
        • North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
        • Kontakt:
        • Huvudutredare:
          • Sarah McGill, MD, MSc
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Rekrytering
        • Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
        • Kontakt:
        • Huvudutredare:
          • Cosby Stone, Jr, MD, MPH
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22908
        • Har inte rekryterat ännu
        • University of Virginia Health System: Division of Asthma & Immunology
        • Huvudutredare:
          • Jeffrey Wilson, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Diagnostiskt 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
Diagnostiskt 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
Experimentell: 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.
Diagnostiskt 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
Diagnostiskt 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Positive Double Blind Food Challenge (DBFC) result to 150 grams of either alpha-gal knockout (KO) pork or wild type (WT) pork.
Tidsram: 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)

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 september 2026

Primärt slutförande (Beräknad)

30 oktober 2031

Avslutad studie (Beräknad)

30 oktober 2032

Studieregistreringsdatum

Först inskickad

17 april 2026

Först inskickad som uppfyllde QC-kriterierna

22 maj 2026

Första postat (Faktisk)

28 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • DAIT CoFAR-13

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

Open access.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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