Alpha-gal Pork Challenge

Placebo Controlled Alpha-gal Pork Challenge

Sponsoren

Hauptsponsor: University of Virginia

Quelle University of Virginia
Kurze Zusammenfassung

This study is investigating the hypothesis that alpha-gal is responsible for the gastrointestinal symptoms that occur in some alpha-gal syndrome subjects following the consumption of mammalian meat. This will be tested by comparing symptoms and immune responses in subjects with alpha-gal syndrome following consumption of "wild-type" pork (which contains alpha-gal) versus consumption of a novel pork product which has been genetically modified to lack alpha-gal (GalSafe pork from Revivicor Inc.).

Gesamtstatus Not yet recruiting
Anfangsdatum 2021-05-01
Fertigstellungstermin 2024-04-30
Primäres Abschlussdatum 2023-04-30
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Composite GI symptom score Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .
Sekundäres Ergebnis
Messen Zeitfenster
Tryptase Serial samples from 0 to 5 hours post-challenge
Histamine/Methyl-histamine Serial samples from 0 to 6 hours post-challenge
11Beta-PGF2-alpha Serial samples from 0 to 6 hours post-challenge
Einschreibung 54
Bedingung
Intervention

Interventionsart: Other

Interventionsname: Pork Challenge

Beschreibung: Double blind oral challenges comparing wild-type and alpha-gal free pork.

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria: Alpha-gal cases: - Age 18-70 - Patient report of episodic GI symptoms within past 6 months that correlated with ingestion of mammalian meat and/or dairy and which improved on a mammalian avoidance diet. - IgE to α-Gal >0.1 IU/mL at screening visit. - Willingness and ability to comply with scheduled visits and study procedures. Control subjects: - Age 18-70 - Regularly consume/tolerate mammalian meat without obvious associated gastrointestinal or skin symptoms. - Have eaten mammalian meat within the past 2 weeks - Willingness and ability to comply with scheduled visits and study procedures. Exclusion Criteria: Alpha-gal cases: - History of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the PI. - IgE to pork which exceeds the value of IgE to α-Gal on screening test - Unexplained, persistent urticaria or pruritis. - Pregnancy, breastfeeding or lack of birth control in women of child-bearing age. - At the discretion of the principal investigator, patients may be excluded due to poorly controlled chronic gastrointestinal conditions including but not limited inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, microscopic colitis), acid reflux/heartburn, history of bariatric surgery or gastric banding, active peptic ulcer disease or any abdominal surgery within the past 2 months. - Patient is unable to swallow food or has poor peripheral access. - Patient has any medical or physiological disorder or condition that, in the opinion of the Investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements. Control subjects: - History of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the PI - Unexplained, persistent urticaria or pruritis. - Poorly controlled chronic gastrointestinal problem - Patient is unable to swallow food or has poor peripheral access - Patient has any medical or physiological disorder or condition that, in the opinion of the Investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: Accepts Healthy Volunteers

Gesamtkontakt

Nachname: Jeffrey Wilson, MD, PhD

Telefon: 434-243-8674

Email: [email protected]

Überprüfungsdatum

2021-03-01

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: University of Virginia

Vollständiger Name des Ermittlers: Jeffrey Wilson, MD

Ermittlertitel: Assistant Professor of Medicine

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Basic Science

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov

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