Alpha-gal Pork Challenge

NCT04828317 | Unknown

• 1 other identifier: HSR200447
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.).

Conditions

Allergy;Food

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Interventions

Pork Challenge OTHER

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Jeffrey Wilson, MD, PhD

CONTACT

434-243-8674; jmw2gc@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 2, 2021
• Study Start: May 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share