Status:
UNKNOWN
Alpha-gal Pork Challenge
Lead Sponsor:
University of Virginia
Conditions:
Allergy;Food
Eligibility:
All Genders
18-70 years
Phase:
NA
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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04828317
Start Date
May 1 2021
End Date
April 30 2024
Last Update
April 2 2021
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