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

29. května 2026 aktualizováno: 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)

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

160

Fáze

Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Spojené státy
- Arkansas
  - Little Rock, Arkansas, Spojené státy, 72202
    - Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
    - Kontakt:
      
      Aprile Wicker
      
      Telefonní číslo: 501-364-1998
      
      E-mail: wickeraj@archildrens.org
    - Vrchní vyšetřovatel:
      
      Stacie Jones, MD
- North Carolina
  - Chapel Hill, North Carolina, Spojené státy, 27599
    - North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
    - Kontakt:
      
      Morgan Goins
      
      Telefonní číslo: 919-445-7031
      
      E-mail: morgan_goins@med.unc.edu
    - Vrchní vyšetřovatel:
      
      Sarah McGill, MD, MSc
- Tennessee
  - Nashville, Tennessee, Spojené státy, 37232
    - Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
- Virginia
  - Charlottesville, Virginia, Spojené státy, 22908
    - University of Virginia Health System: Division of Asthma & Immunology
    - Vrchní vyšetřovatel:
      
      Jeffrey Wilson, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dítě
Dospělý

Přijímá zdravé dobrovolníky

Popis

Inclusion Criteria:

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

Exclusion Criteria:

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Diagnostický
Přidělení: Randomizované
Intervenční model: Crossover Assignment
Maskování: Dvojnásobek

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Experimentální: 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.	Diagnostický 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 Diagnostický 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
Experimentální: 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.	Diagnostický 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 Diagnostický 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

Skupina účastníků / Arm

Intervence / Léčba

Experimentální: 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.

Diagnostický 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

Diagnostický 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

Experimentální: 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.

Diagnostický 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

Diagnostický 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

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Positive Double Blind Food Challenge (DBFC) result to 150 grams of either alpha-gal knockout (KO) pork or wild type (WT) pork. Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Alpha-gal sub-phenotype as determined by symptoms resulting from Double Blind Food Challenge (DBFC) to wild-type (WT) pork. Časové okno: 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 Časové okno: 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. Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Institute of Allergy and Infectious Diseases (NIAID)

Spolupracovníci

Consortium for Food Allergy Research (CoFAR)

Allergy & Asthma Statistical and Clinical Coordinating Center: Rho, Inc

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. června 2026

Primární dokončení (Odhadovaný)

30. září 2031

Dokončení studie (Odhadovaný)

30. září 2032

Termíny zápisu do studia

První předloženo

17. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

22. května 2026

První zveřejněno (Aktuální)

28. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

DAIT CoFAR-13

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

Open access.

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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