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NCT07611435 · ClinicalTrials.gov registry record · Phase 2
Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Not yet
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT07611435 is a Phase 2 study that has not yet begun recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 160 participants.
The verdict
NCT07611435, a Phase 2 study, has not yet begun recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
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)
Interventions
- DIAGNOSTIC_TEST DBFC with 150g of Alpha-gal Knock Out (KO) pork
- DIAGNOSTIC_TEST DBFC with 150g of Wild Type (WT) pork
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2026-07-30 |
| Est. Completion | 2032-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07611435
The ClinicalTrials.gov registry entry for NCT07611435 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DBFC with 150g of Alpha-gal Knock Out (KO) pork is the first listed.
NCT07611435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07611435 about?
NCT07611435 is a clinical study titled "Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG". 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. Eac...
What is the current status of trial NCT07611435?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2026-07-30. Estimated completion is 2032-09-30.
What interventions are being tested in trial NCT07611435?
The interventions under investigation include: DBFC with 150g of Alpha-gal Knock Out (KO) pork (DIAGNOSTIC_TEST), DBFC with 150g of Wild Type (WT) pork (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07611435?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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