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

Study acronym: BeACON4AG
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later Sep 30, 2031 → Oct 30, 2031
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

  1. Start date changed from estimate of Sep 15, 2026 to Sep 21, 2026 Eligibility criteria expanded, about 21 words · Site details revised at 3 of 4 sites · Collaborators: details revised at 1 of 2 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Site details revised at 3 of 4 sites
    • Collaborators: details revised at 1 of 2 entries
  2. Recruitment opened Start date: Jul 30, 2026 to Sep 15, 2026 · Primary completion pushed from Sep 30, 2031 to Oct 30, 2031 · Completion pushed from Sep 30, 2032 to Oct 30, 2032 · 1 morev4 Show 4 more changesShow less
    • Start date: Jul 30, 2026 to Sep 15, 2026
    • Primary completion pushed from Sep 30, 2031 to Oct 30, 2031
    • Completion pushed from Sep 30, 2032 to Oct 30, 2032
    • Site details revised at 4 of 4 sites
  3. Start date: Jun 15, 2026 to Jul 30, 2026v3
  4. Start date: Jun 1, 2026 to Jun 15, 2026v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT07611435
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Consortium for Food Allergy Research (CoFAR), Allergy & Asthma Statistical and Clinical Coordinating Center: Rho, Inc
Conditions Alpha-Gal Syndrome, Allergy
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov