Actively Recruiting
GI Alpha-Gal Study
Led by University of North Carolina, Chapel Hill · Updated on 2025-10-20
30
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
R
Revivicor, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GI Alpha-Gal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- History of gastrointestinal alpha-gal allergy with elevated alpha-gal IgE (>0.1 U/L) and symptoms like abdominal pain, diarrhea, nausea, or vomiting within the last 5 years
- Symptoms occurring at least once monthly for at least two months
- Completed symptom questionnaire on frequency and severity of symptoms in the 3 months before diagnosis
- Experienced symptom improvement on a mammalian meat-free diet for at least one month
- Elevated alpha-gal IgE on screening if no recent positive test
- Willing to avoid certain medications (NSAIDs, leukotriene modifiers, steroids) 14 days before challenge
- Willing to sign informed consent
You will not qualify if you...
- Significant health conditions that increase risk from anaphylaxis treatment (e.g., heart disease, unstable angina, arrhythmias)
- Allergy to mannitol
- Pregnant females
- History of chronic gastrointestinal diseases like inflammatory bowel disease, celiac disease, or chronic pancreatitis with ongoing symptoms
- Recent diarrhea, moderate to severe abdominal pain, or vomiting within 10 days before challenge
- History of severe allergic reaction to mammalian meat causing respiratory or cardiopulmonary symptoms
- Unwillingness to receive intramuscular epinephrine
- Planned use of omalizumab within 6 months
- Planned use of systemic steroids within 28 days
- Planned use of leukotriene modifiers within 14 days
- Unable to stop NSAIDs 14 days before challenge
- Contraindications for transnasal endoscopy (for those undergoing biopsy), including history of head and neck cancer, anatomical deformities, or severe anxiety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
S
Sarah McGill, MD
CONTACT
S
Shilpa Karanjit, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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