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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.).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pork Challenge | Other | Double blind oral challenges comparing wild-type and alpha-gal free pork. |
| 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. . |
| 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 |
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Inclusion Criteria:
Alpha-gal cases:
Control subjects:
Exclusion Criteria:
Alpha-gal cases:
Control subjects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Wilson, MD, PhD | Contact | 434-243-8674 | jmw2gc@virginia.edu |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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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 |