Alpha-gal Pork Challenge

Placebo Controlled Alpha-gal Pork Challenge

Sponsors

Commanditaire principal: University of Virginia

La source University of Virginia
Bref résumé

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.).

Situation globale Not yet recruiting
Date de début 2021-05-01
Date d'achèvement 2024-04-30
Date d'achèvement principale 2023-04-30
Phase N/A
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Composite GI symptom score Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .
Résultat secondaire
Mesure Plage de temps
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
Inscription 54
État
Intervention

Type d'intervention: Other

Nom de l'intervention: Pork Challenge

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

Admissibilité

Critères:

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.

Le sexe: All

Âge minimum: 18 Years

Âge maximum: 70 Years

Volontaires en santé: Accepts Healthy Volunteers

Contact général

Nom de famille: Jeffrey Wilson, MD, PhD

Téléphone: 434-243-8674

Email: [email protected]

Date de vérification

2021-03-01

Partie responsable

Type: Principal Investigator

Affiliation des enquêteurs: University of Virginia

Nom complet de l'enquêteur: Jeffrey Wilson, MD

Titre d'enquêteur: Assistant Professor of Medicine

A un accès étendu No
Parcourir l'état
Données patient No
Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Single Group Assignment

Objectif principal: Basic Science

Masquage: Double (Participant, Investigator)

La source: ClinicalTrials.gov

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