Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13)
National Institute of Allergy and Infectious Diseases (NIAID)
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)
Eligibility
- Age range
- 12–50 years
- Sex
- All
- Healthy volunteers
- No
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 Dr…