Irritable Bowel Syndrome Clinical Trial
Official title:
Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | October 17, 2025 |
Est. primary completion date | October 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 a-gal allergy (a-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 a-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. 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Revivicor, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 6 hours post ingestion | |
Primary | 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). | 6 hours post ingestion | |
Primary | 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. | 0- 6 hours post ingestion | |
Primary | 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. | 0-6 hours post ingestion | |
Primary | 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 | 0 hours (prior to ingestion) | |
Primary | 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. | 2 hours post ingestion | |
Primary | 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. | 4 hours post ingestion | |
Primary | 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 | 6 hours post ingestion | |
Primary | Serum tryptase at timepoint 0 | Serum tryptase- serum tryptase levels will be quantified. | 0 hours (prior to ingestion) | |
Primary | Serum tryptase at 2 hours | Serum tryptase- serum tryptase levels will be quantified. | 2 hours post ingestion | |
Primary | Serum tryptase at 4 hours | Serum tryptase- serum tryptase levels will be quantified. | 4 hours post ingestion | |
Primary | Serum tryptase at 6 hours | Serum tryptase- serum tryptase levels will be quantified. | 6 hours post ingestion | |
Primary | 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. | 6 hours post ingestion | |
Primary | 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. | 6 hours post ingestion | |
Primary | 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. | 6 hours post ingestion | |
Primary | 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. | 6 hours post ingestion |
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