GI Alpha-Gal Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 transnasal upper endoscopy (TNE) will be performed on each challenge day, pre-challenge, at hour 0 and post-challenge, at hour 6. During the TNE, esophagus, stomach and small bowel samples will be collected. Gastrointestinal pathology samples will be evaluated for inflammatory cells and also biobanked for further messenger RNA (mRNA) sequencing studies. Blood and urine will be collected during each challenge. Samples will be transported to a lab and analyzed for tryptase, basophil activation, and lactulose/ mannitol levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06268717
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact	Sarah McGill, MD
Phone	+1 (919) 966-7047
Email	mcgills@email.unc.edu
Status	Recruiting
Phase	N/A
Start date	October 17, 2023
Completion date	October 17, 2025

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