Food challenge study for gastrointestinal alpha-gal allergy
Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)
This study is testing how pork meat with and without a specific sugar affects people with gastrointestinal alpha-gal allergy to better understand their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Drugs / interventions | omalizumab |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06268717 on ClinicalTrials.gov |
What this trial studies
This study investigates gastrointestinal alpha-gal allergy through a double-blind, crossover food challenge involving pork meat with and without alpha-gal sugar. Participants will undergo two challenges separated by a 10-day washout period, during which they will consume lactulose and C13 mannitol. A transnasal upper endoscopy will be performed on challenge days to collect samples from the gastrointestinal tract for analysis of inflammatory cells and biobanking for future studies. Blood and urine samples will also be collected to assess various biomarkers related to the allergy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of gastrointestinal alpha-gal allergy and a history of related symptoms.
Not a fit: Patients who do not have a confirmed diagnosis of gastrointestinal alpha-gal allergy or who do not experience symptoms related to this condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of alpha-gal syndrome and improved management strategies for patients suffering from gastrointestinal symptoms.
How similar studies have performed: While studies on alpha-gal syndrome exist, this specific approach using a double-blind food challenge is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Sarah McGill, MD — University of North Carolina, Chapel Hill
- Study coordinator: Sarah McGill, MD
- Email: mcgills@email.unc.edu
- Phone: +1 (919) 966-7047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.