Status:

RECRUITING

GI Alpha-Gal Study

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

Revivicor, Inc

Conditions:

Alpha-Gal Syndrome

Irritable Bowel Syndrome

Eligibility:

All Genders

18-99 years

Phase:

NA

Brief 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 pathophys...

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 s...

Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Key Trial Info

Start Date :

October 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 2 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06268717

Start Date

October 17 2023

End Date

June 2 2026

Last Update

October 20 2025

Active Locations (1)

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599