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

4 de setembro de 2026 atualizado por: 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)

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

160

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72202
        • Ainda não está recrutando
        • Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
        • Contato:
        • Investigador principal:
          • Stacie Jones, MD
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • Ainda não está recrutando
        • North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
        • Contato:
        • Investigador principal:
          • Sarah McGill, MD, MSc
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Recrutamento
        • Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
        • Contato:
        • Investigador principal:
          • Cosby Stone, Jr, MD, MPH
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • Ainda não está recrutando
        • University of Virginia Health System: Division of Asthma & Immunology
        • Investigador principal:
          • Jeffrey Wilson, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Teste de diagnostico: 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
Teste de diagnostico: 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.
Teste de diagnostico: 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
Teste de diagnostico: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Positive Double Blind Food Challenge (DBFC) result to 150 grams of either alpha-gal knockout (KO) pork or wild type (WT) pork.
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Alpha-gal sub-phenotype as determined by symptoms resulting from Double Blind Food Challenge (DBFC) to wild-type (WT) pork.
Prazo: 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
Prazo: 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.
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Institute of Allergy and Infectious Diseases (NIAID)

Colaboradores

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

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de setembro de 2026

Conclusão Primária (Estimado)

30 de outubro de 2031

Conclusão do estudo (Estimado)

30 de outubro de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

17 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de maio de 2026

Primeira postagem (Real)

28 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DAIT CoFAR-13

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

Open access.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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