CompletedNCT06268717Updated Sep 8, 2026

GI Alpha-Gal Study

An interventional study of Ground pork containing alpha-gal and Pork meat not containing alpha-gal in Alpha-Gal Syndrome, Irritable Bowel Syndrome and Diarrhea, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Other

From the registry’s dates

Registered 3 months after the study started (first participant enrolled Oct 2023, registered Feb 2024).

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: All

Study 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.

Read the 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. The principal investigator may take pictures of the skin changes from participants who have skin changes such as rashes, hives, flushing, etc. during the challenge visits to assess the adverse events after getting consent.

Conditions studied

Alpha-Gal Syndrome
Irritable Bowel Syndrome
Diarrhea
Abdominal Pain
Vomiting

Browse trials for

Keywords

Alpha-Gal Syndrome
diarrhea
abdominal pain
vomiting

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 30 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Active comparator
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.
Other: Ground pork containing alpha-gal · Other: Pork meat not containing alpha-gal
Active comparator
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.
Other: Ground pork containing alpha-gal · Other: Pork meat not containing alpha-gal

Interventions

OtherGround pork containing alpha-gal
150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once
OtherPork meat not containing alpha-gal
150 grams of cooked, ground pork meat not containing alpha-gal sugar

What researchers measure

Primary outcomes

Allergic reaction (food challenge positive)
Presence of allergic reaction within 6 hours of the challenge. Reported as dichotomous: food challenge positive (reaction) or food challenge negative (no reaction).
Time frame: 6 hours post ingestion
No allergic reaction (food challenge negative)
No allergic reaction within 6 hours of the challenge. Reported as dichotomous: food challenge positive (reaction) or food challenge negative (no reaction).
Time frame: 6 hours post ingestion
Lactulose excretion
C13 mannitol quantification with high-performance liquid chromatography- C13 mannitol excreted in the urine in the six hours following ingestion will be measured as a marker of intestinal permeability.
Time frame: 0- 6 hours post ingestion
C13 mannitol excretion
C13 mannitol quantification with high-performance liquid chromatography- C13 mannitol excreted in the urine in the six hours following ingestion will be measured as a marker of intestinal permeability.
Time frame: 0-6 hours post ingestion
Basophil activation threshold response at timepoint 0
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation
Time frame: 0 hours (prior to ingestion)
Basophil activation threshold response at 2 hours
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation.
Time frame: 2 hours post ingestion
Basophil activation threshold response at 4 hours
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation.
Time frame: 4 hours post ingestion
Basophil activation threshold response at 6 hours
Basophil activation threshold responses - peripheral blood basophils will be isolated and stimulated with mammal-based extracts to create a dose-response curve for concentrations of antigen leading to CD63 activation. Results pre- and post- pork challenge will be compared to assess for changes in basophil responses
Time frame: 6 hours post ingestion
Serum tryptase at timepoint 0
Serum tryptase- serum tryptase levels will be quantified.
Time frame: 0 hours (prior to ingestion)
Serum tryptase at 2 hours
Serum tryptase- serum tryptase levels will be quantified.
Time frame: 2 hours post ingestion
Serum tryptase at 4 hours
Serum tryptase- serum tryptase levels will be quantified.
Time frame: 4 hours post ingestion
Serum tryptase at 6 hours
Serum tryptase- serum tryptase levels will be quantified.
Time frame: 6 hours post ingestion
Mast cell count on stomach biopsies (per high powered field (hpf))
The number of mast cells will be counted at high-powered field on biopsy specimens of the stomach.
Time frame: 6 hours post ingestion
Mast cell count on small bowel biopsies (per high powered field (hpf))
The number of mast cells will be counted at high-powered field on biopsy specimens of the small bowel.
Time frame: 6 hours post ingestion
Eosinophil cell count on stomach biopsies (per high powered field (hpf))
The number of eosinophil cells will be counted at high-powered field on biopsy specimens of the stomach.
Time frame: 6 hours post ingestion
Eosinophil cell count on small bowel biopsies (per high powered field (hpf))
The number of eosinophil cells will be counted at high-powered field on biopsy specimens of the small bowel.
Time frame: 6 hours post ingestion

Secondary outcomes

GI Symptom Rating Score (GSRS)
The Gastrointestinal Symptom Rating Scale (GSRS) assesses gastrointestinal symptoms as experienced by participants in the 24-hours following a challenge. The scale covers 17 specific G1 symptoms, each rated on a 0-5 scale where 0 (no symptoms), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe), 5 (very severe)
Time frame: 24 hours post challenge

Study locations

1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599, United States

References and documents

Individual participant data

Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06268717
Lead sponsor: University of North Carolina, Chapel Hill
Collaborators: Revivicor, Inc, American College of Gastroenterology
Responsible party: Sponsor
First posted: Feb 20, 2024
Start date: Oct 17, 2023
Primary completion: Jun 2, 2026
Completion: Jun 2, 2026
Last update: Sep 8, 2026

Study contacts

Sarah McGill, MD

principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

red meat allergy

Other studies from this sponsor

University of North Carolina, Chapel Hill

Start the discussion