Back to resultsAlpha-gal Pork Challenge
Primary Purpose
Allergy;Food
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pork Challenge
Sponsored by
About this trial
This is an interventional basic science trial for Allergy;Food
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Tryptase
Serum tryptase levels (ng/mL) will be quantified with ImmunoCap comparing post-challenge levels with baseline.
Histamine/Methyl-histamine
Histamine and methyl-histamine (ng/mL) from serum and urine samples will be quantified with ELISA comparing post-challenge to baseline.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04828317
Brief Title
Alpha-gal Pork Challenge
Official Title
Placebo Controlled Alpha-gal Pork Challenge
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy;Food
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Pork Challenge
Intervention Description
Double blind oral challenges comparing wild-type and alpha-gal free pork.
Primary Outcome Measure Information:
Title
Composite GI symptom score
Description
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.
Time Frame
Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .
Secondary Outcome Measure Information:
Title
Tryptase
Description
Serum tryptase levels (ng/mL) will be quantified with ImmunoCap comparing post-challenge levels with baseline.
Time Frame
Serial samples from 0 to 5 hours post-challenge
Title
Histamine/Methyl-histamine
Description
Histamine and methyl-histamine (ng/mL) from serum and urine samples will be quantified with ELISA comparing post-challenge to baseline.
Time Frame
Serial samples from 0 to 6 hours post-challenge
Title
11Beta-PGF2-alpha
Description
11Beta-PGF2-alpha (pg/mL), a PGD2 metabolite, will be quantified in serum and urine with ELISA comparing post-challenge to baseline
Time Frame
Serial samples from 0 to 6 hours post-challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Wilson, MD, PhD
Phone
434-243-8674
Email
jmw2gc@virginia.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Alpha-gal Pork Challenge
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