RECRUITING

GI Alpha-Gal Study

Conditions

Alpha-Gal Syndrome Irritable Bowel Syndrome Diarrhea Abdominal Pain Vomiting

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)

Quick Facts

Study Start:2023-10-17

Study Completion:2025-10-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06268717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 3 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.	* 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

Inclusion Criteria

Exclusion 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 3 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.

* 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

Contacts and Locations

Study Contact

Sarah McGill, MD

CONTACT

+1 (919) 966-7047

mcgills@email.unc.edu

Shilpa Karanjit, MPH

CONTACT

919-843-8519

Shilpa_Karanjit@med.unc.edu

Principal Investigator

Sarah McGill, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Sarah McGill, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-17

Study Completion Date2025-10-17

Study Record Updates

Study Start Date2023-10-17

Study Completion Date2025-10-17

Terms related to this study

Keywords Provided by Researchers

Alpha-Gal Syndrome
diarrhea
abdominal pain
vomiting

Additional Relevant MeSH Terms

Alpha-Gal Syndrome
Irritable Bowel Syndrome
Diarrhea
Abdominal Pain
Vomiting