Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)
University of North Carolina, Chapel Hill
Summary
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.
Description
Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat with alpha gal sugar; one challenge will contain pork meat without the alpha gal sugar. During the challenges, participants will drink lactulose and C13 mannitol dissolved in water. The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded. On consenting patients, a…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The subject is at least 18 years of age. * The subject has a history of gastrointestinal alpha-gal allergy defined by elevated test for α-gal allergy (α-gal IgE \>0.1 U/L) due to complaints of either abdominal pain or discomfort, diarrhea, nausea with or without vomiting, or a combination of those complaints, within the last 5 years. The subjects must have experienced one or more of the four symptoms at least once monthly for at least two months. The subjects will fill out a symptom questionnaire of the presence of these four symptoms (abdominal pain or discomfort, diarr…
Interventions
- OtherGround pork containing alpha-gal
150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once
- OtherPork meat not containing alpha-gal
150 grams of cooked, ground pork meat not containing alpha-gal sugar
Location
- University of North Carolina at Chapel HillChapel Hill, North Carolina