GI Alpha-Gal Study

Completed · Not applicable

Conditions studied: Alpha-Gal Syndrome, Irritable Bowel Syndrome, Diarrhea, Abdominal Pain, Vomiting

In brief

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.

Key facts

Study ID

NCT06268717

Run by

University of North Carolina, Chapel Hill

People needed

30

Starts

2023-10-17

Expected to finish

2026-06-02

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, diarrhea, nausea, vomiting), frequency and severity (mild, moderate, or severe) for the 3 months prior to diagnosis.
• The subject has experienced symptomatic improvement on a mammalian meat-free diet over at least a month's time, defined by saying "yes" to the following question: "On the alpha-gal avoidant diet, have you had adequate relief of gastrointestinal symptoms?"
• The subject has elevated α-gal IgE titer on screening for the trial if they do not have a positive titer within 6 months of enrollment.
• The subject is willing to not take nonsteroidal anti-inflammatory medications, leukotriene modifiers or steroids 14 days prior to challenge.
• The subject is willing to sign the informed consent form.

You may not qualify if…

• The subject has health conditions that would pose a significant threat in the face of anaphylaxis or treatment for anaphylaxis (e.g., cardiac disease, unstable angina pectoris, arrhythmias).
• The subject is allergic to mannitol.
• If female, the subject is pregnant.
• The subject has a history of chronic GI conditions, including inflammatory bowel disease, celiac disease, chronic pancreatitis with continued symptoms (experience moderate-severe abdominal pain, diarrhea, or nausea/vomiting that occur more frequently than once weekly)
• The subject has diarrhea (one or more loose stools that conform to the container), moderate to severe abdominal pain, or vomiting within 10 days prior to the challenge.
• The subject has a history of severe allergic reaction on mammalian meat ingestion (respiratory distress, chest pain or cardiopulmonary compromise)
• The subject is unwilling to receive intramuscular epinephrine.
• The subject is anticipated to use omalizumab within 6 months of enrollment.
• The subject is anticipated to use systemic steroids within 28 days of food challenge.
• The subject is anticipated to use leukotriene modifier within 14 days of food challenge.
• The subject is unable to not use nonsteroidal anti-inflammatory drugs for 14 days prior to challenge.
• Additional Exclusion Criteria for Subjects Undergoing Transnasal Endoscopy and Biopsy
• Known conditions that are contraindications to transnasal endoscopy, or in the opinion of the investigator any condition that would interfere with the study objectives.
• History of head and neck malignancy or anatomical deformities of the nasopharynx
• Severe anxiety

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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