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Pork challenge reveals hidden gut reactions in Alpha-Gal syndrome

NCT ID NCT06268717

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study looked at 30 adults with Alpha-Gal syndrome, a condition where eating red meat causes allergic reactions. Participants ate cooked ground pork with or without a sugar called alpha-gal, then researchers checked for allergic reactions, gut symptoms, and changes in immune cells. The goal was to better understand why some people get stomach pain, diarrhea, or vomiting after eating meat.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cooked ground pork (with or without alpha-gal sugar)
What this could lead to
If successful, this could clarify why some people with Alpha-Gal syndrome get stomach pain, diarrhea, or vomiting after eating red meat.
What could go wrong
This is a small, completed study with only 30 participants. It aims to understand the condition, not test a treatment, so direct benefits are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

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