Clinical trial NCT04828317: Alpha-gal Pork Challenge
Official title: Placebo Controlled Alpha-gal Pork Challenge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergy;Food
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.).


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.

Primary outcomes:
measure: Composite GI symptom score
timeFrame: Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .
Secondary outcomes:
measure: Tryptase
timeFrame: Serial samples from 0 to 5 hours post-challenge
measure: Histamine/Methyl-histamine
timeFrame: Serial samples from 0 to 6 hours post-challenge
measure: 11Beta-PGF2-alpha
timeFrame: Serial samples from 0 to 6 hours post-challenge
Other outcomes:
Locations:
Study officials:
References: