search
Back to results

Alpha-gal Pork Challenge

Primary Purpose

Allergy;Food

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pork Challenge
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergy;Food

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 24, 2021
    Last Updated
    March 31, 2021
    Sponsor
    University of Virginia
    search

    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

    Learn more about this trial

    Alpha-gal Pork Challenge

    We'll reach out to this number within 24 hrs