protocolSection identificationModule nctId: NCT06268717, orgStudyIdInfo id: 23-0316, briefTitle: GI Alpha-Gal Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-10-17, completionDateStruct date: 2025-10-17, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Revivicor, Inc, descriptionModule briefSummary: 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., conditionsModule conditions: Alpha-Gal Syndrome, conditions: Irritable Bowel Syndrome, conditions: Diarrhea, conditions: Abdominal Pain, conditions: Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Double-blind crossover. 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 containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar., primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Ground pork containing alpha-gal, interventions name: Pork meat not containing alpha-gal, outcomesModule primaryOutcomes measure: Allergic reaction (food challenge positive), primaryOutcomes measure: No allergic reaction (food challenge negative), primaryOutcomes measure: Lactulose excretion, primaryOutcomes measure: C13 mannitol excretion, primaryOutcomes measure: Basophil activation threshold response at timepoint 0, primaryOutcomes measure: Basophil activation threshold response at 2 hours, primaryOutcomes measure: Basophil activation threshold response at 4 hours, primaryOutcomes measure: Basophil activation threshold response at 6 hours, primaryOutcomes measure: Serum tryptase at timepoint 0, primaryOutcomes measure: Serum tryptase at 2 hours, primaryOutcomes measure: Serum tryptase at 4 hours, primaryOutcomes measure: Serum tryptase at 6 hours, primaryOutcomes measure: Mast cell count on stomach biopsies (per high powered field (hpf)), primaryOutcomes measure: Mast cell count on small bowel biopsies (per high powered field (hpf)), primaryOutcomes measure: Eosinophil cell count on stomach biopsies (per high powered field (hpf)), primaryOutcomes measure: Eosinophil cell count on small bowel biopsies (per high powered field (hpf)), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Sarah McGill, MD, role: CONTACT, phone: 919-966-7047, email: mcgills@email.unc.edu, contacts name: Sarah McGill, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False