Study on Alpha-Gal Syndrome and Pork Challenges
This study is looking at how people with Alpha-Gal Syndrome (AGS), a type of allergy, react to different kinds of pork. Researchers want to see if eating pork where the alpha-gal sugar has been removed (alpha-gal Knock Out or KO pork) causes fewer allergic reactions compared to regular pork (Wild Type or WT pork). You would eat both types of pork on separate days, with at least 8 days in between. The study is for people aged 12 to 50 who have symptoms of Alpha-Gal Syndrome. The main goal is to find out if KO pork is less likely to cause a positive allergic reaction than WT pork.
- Study design
- This is a randomized, double-blind study involving 160 participants. Each participant will try both types of pork, serving as their own comparison.
- What's involved
- You would participate in two oral food challenges, eating 150 grams of pork on each occasion. There will be at least an 8-day break between these challenges.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your reactions to the pork challenges will be measured at Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Leonard Bacharier, M.D. · STUDY_CHAIR · Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
- Rachel Robison, M.D. · STUDY_CHAIR · Vanderbilt University Medical Center: Division of Allergy, Pulmonary and Critical Care Medicine
Who to contact
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What this trial measures
- Positive Double Blind Food Challenge (DBFC) result to 150 grams of either alpha-gal knockout (KO) pork or wild type (WT) pork.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.