Alpha-gal Pork Challenge

Placebo Controlled Alpha-gal Pork Challenge

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.).

Study Overview

• Status: Not yet recruiting
• Conditions: Allergy;Food
• Intervention / Treatment: Other: Pork Challenge

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey Wilson, MD, PhD; Phone Number: 434-243-8674; Email: jmw2gc@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite GI symptom score	GI symptoms will be assessed using modified FAST diary. Score is determined from a survey of five gastrointestinal symptoms obtained at 0,1,3,5 hours following oral pork challenge. Symptoms are measured via numerical rating scale (1-5) and aggregate score will be calculated.	Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tryptase	Serum tryptase levels (ng/mL) will be quantified with ImmunoCap comparing post-challenge levels with baseline.	Serial samples from 0 to 5 hours post-challenge
Histamine/Methyl-histamine	Histamine and methyl-histamine (ng/mL) from serum and urine samples will be quantified with ELISA comparing post-challenge to baseline.	Serial samples from 0 to 6 hours post-challenge
11Beta-PGF2-alpha	11Beta-PGF2-alpha (pg/mL), a PGD2 metabolite, will be quantified in serum and urine with ELISA comparing post-challenge to baseline	Serial samples from 0 to 6 hours post-challenge

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: HSR200447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No