NCT06268717

GI Alpha-Gal Study

Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alpha-Gal Syndrome
• Irritable Bowel Syndrome
• Diarrhea
• Abdominal Pain
• Vomiting

Interventions

Type	Name	Description
OTHER	Ground pork containing alpha-gal	150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once
OTHER	Pork meat not containing alpha-gal	150 grams of cooked, ground pork meat not containing alpha-gal sugar

Timeline

• Start date: 2023-10-17
• Primary completion: 2026-06-02
• Completion: 2026-06-02
• First posted: 2024-02-20
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States