Actively Recruiting
Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)
Led by University of North Carolina, Chapel Hill · Updated on 2025-10-20
30
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating gastrointestinal alpha-gal allergy by conducting a double-blind, crossover food challenge study. Participants diagnosed with this allergy will undergo two food challenges using pork meat, one containing alpha-gal sugar and one without, to study the allergic response and understand the symptoms and underlying biology. This research also aims to explore the pathophysiology causing their symptoms using detailed tissue and blood analyses. Each participant will be randomly assigned to receive either the pork containing alpha-gal or the pork without it first, followed by the other challenge after a washout period of at least 10 days. During each challenge, participants will consume 150 grams of cooked ground pork and drink lactulose and C13 mannitol dissolved in water. Researchers, including the principal investigator and coordinators, will be blinded to the challenge content. Transnasal upper endoscopy will be performed before and six hours after each challenge to collect tissue samples from the esophagus, stomach, and small bowel for inflammation and gene studies. Blood and urine samples will also be collected for laboratory analysis. Participants will be monitored closely during the challenges with evaluations including allergic reactions, basophil activation, serum tryptase levels, and cell counts from biopsies taken during endoscopy. Symptoms will be tracked using questionnaires 24 hours after the challenge. The study involves detailed testing and sample collection to measure immune responses and gastrointestinal symptoms related to alpha-gal allergy. The total participation includes both challenge days with at least a 10-day washout period between them.
CONDITIONS
Brief Title
GI Alpha-Gal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject is at least 18 years of age.
- The subject has a history of gastrointestinal alpha-gal allergy with elevated alpha-gal IgE (>0.1 U/L) and symptoms such as abdominal pain, diarrhea, nausea, or vomiting experienced at least once monthly for two months.
- The subject has experienced symptom improvement on a mammalian meat-free diet for at least one month.
- The subject has an elevated alpha-gal IgE titer within 6 months of enrollment or will be screened for it.
- The subject agrees to avoid nonsteroidal anti-inflammatory drugs, leukotriene modifiers, or steroids for 14 days before the challenge.
- The subject is willing to sign the informed consent form.
You will not qualify if you...
- The subject has health conditions that pose significant risk during anaphylaxis, such as cardiac disease, unstable angina, or arrhythmias.
- The subject is allergic to mannitol.
- If female, the subject is pregnant.
- The subject has chronic gastrointestinal conditions such as inflammatory bowel disease, celiac disease, or chronic pancreatitis with frequent symptoms.
- The subject has moderate to severe diarrhea, abdominal pain, or vomiting within 10 days before the challenge.
- The subject has a history of severe allergic reaction to mammalian meat ingestion.
- The subject is unwilling to receive intramuscular epinephrine.
- The subject plans to use omalizumab within 6 months of enrollment.
- The subject plans to use systemic steroids within 28 days of the challenge.
- The subject plans to use leukotriene modifiers within 14 days of the challenge.
- The subject cannot avoid nonsteroidal anti-inflammatory drugs for 14 days before the challenge.
- For those undergoing transnasal endoscopy and biopsy: has contraindications to the procedure, history of head/neck malignancy or anatomical deformities, or severe anxiety.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will have 1 screening and enrollment visit.
Duration - 1 day
Participants undergo a double-blind food challenge by consuming 150 grams of cooked, ground pork meat containing alpha-gal sugar. During the challenge, participants drink lactulose and C13 mannitol dissolved in water. A transnasal upper endoscopy (TNE) is performed pre-challenge and 6 hours post-challenge to collect gastrointestinal samples. Blood and urine samples are collected during the challenge for analysis.
2 visits on challenge day (pre-challenge and 6 hours post-challenge, in-person)
Duration - More than 10 days
Participants have a washout period of at least 10 days between the two food challenges to allow for clearance of the previous challenge effects.
No visits required during washout
Duration - 1 day
Participants undergo a double-blind food challenge by consuming 150 grams of cooked, ground pork meat without alpha-gal sugar. During the challenge, participants drink lactulose and C13 mannitol dissolved in water. A transnasal upper endoscopy (TNE) is performed pre-challenge and 6 hours post-challenge to collect gastrointestinal samples. Blood and urine samples are collected during the challenge for analysis.
2 visits on challenge day (pre-challenge and 6 hours post-challenge, in-person)
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
S
Shilpa Karanjit, MPH
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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