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Alpha-gal Pork Challenge

Study Purpose

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.).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04828317
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Virginia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergy;Food

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Jeffrey Wilson, MD, PhD

jmw2gc@virginia.edu

434-243-8674

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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