This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Allergic reaction (food challenge positive)
Timeframe: 6 hours post ingestion
No allergic reaction (food challenge negative)
Timeframe: 6 hours post ingestion
Lactulose excretion
Timeframe: 0- 6 hours post ingestion
C13 mannitol excretion
Timeframe: 0-6 hours post ingestion
Basophil activation threshold response at timepoint 0
Timeframe: 0 hours (prior to ingestion)
Basophil activation threshold response at 2 hours
Timeframe: 2 hours post ingestion
Basophil activation threshold response at 4 hours
Timeframe: 4 hours post ingestion
Basophil activation threshold response at 6 hours
Timeframe: 6 hours post ingestion
Serum tryptase at timepoint 0
Timeframe: 0 hours (prior to ingestion)
Serum tryptase at 2 hours
Timeframe: 2 hours post ingestion
Serum tryptase at 4 hours
Timeframe: 4 hours post ingestion
Serum tryptase at 6 hours
Timeframe: 6 hours post ingestion
Mast cell count on stomach biopsies (per high powered field (hpf))
Timeframe: 6 hours post ingestion
Mast cell count on small bowel biopsies (per high powered field (hpf))
Timeframe: 6 hours post ingestion
Eosinophil cell count on stomach biopsies (per high powered field (hpf))
Timeframe: 6 hours post ingestion
Eosinophil cell count on small bowel biopsies (per high powered field (hpf))
Timeframe: 6 hours post ingestion