Alpha-gal Pork Challenge

NCT ID: NCT04828317

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Interventions

Pork Challenge

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Wilson, MD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jeffrey Wilson, MD, PhD

Role: CONTACT

jmw2gc@virginia.edu

434-243-8674

Other Identifiers

HSR200447

Identifier Type: -

Identifier Source: org_study_id