GI Alpha-Gal Study

NCT ID: NCT06268717

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2026-06-02

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugar

Participants receive a food challenge, consuming pork meat that contains alpha-gal. After a \>10-day washout period, participants undergo a food challenge with pork which does not contain alpha-gal.

Group Type: ACTIVE_COMPARATOR

Ground pork containing alpha-gal

Intervention Type: OTHER

150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once

Pork meat not containing alpha-gal

Intervention Type: OTHER

150 grams of cooked, ground pork meat not containing alpha-gal sugar

Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal

Participants receive a food challenge consuming pork meat that does not contain alpha-gal sugar. After a \>10-day washout period, participants undergo a food challenge with pork which does contain alpha-gal.

Group Type: ACTIVE_COMPARATOR

Ground pork containing alpha-gal

Intervention Type: OTHER

150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once

Pork meat not containing alpha-gal

Intervention Type: OTHER

150 grams of cooked, ground pork meat not containing alpha-gal sugar

Interventions

Ground pork containing alpha-gal

150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once

Intervention Type: OTHER

Pork meat not containing alpha-gal

150 grams of cooked, ground pork meat not containing alpha-gal sugar

Intervention Type: OTHER

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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revivicor, Inc

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah McGill, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah McGill, MD

Role: CONTACT

mcgills@email.unc.edu

+1 (919) 966-7047

Shilpa Karanjit, MPH

Role: CONTACT

Shilpa_Karanjit@med.unc.edu

919-843-8519

Facility Contacts

Sarah McGill, MD

Role: primary

mcgills@email.unc.edu

919-966-7047

Other Identifiers

23-0316

Identifier Type: -

Identifier Source: org_study_id