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Alpha-gal Pork Challenge

Sponsor
University of Virginia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04828317
Collaborator
(none)
54
Enrollment
36
Anticipated Duration (Months)

Study Details

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.).

Condition or Disease Intervention/Treatment Phase
  • Other: Pork Challenge
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Placebo Controlled Alpha-gal Pork Challenge
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Composite GI symptom score [Score is calculated from survey of gastrointestinal symptoms between 1 and 5 hours after challenge. .]

    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

  1. Tryptase [Serial samples from 0 to 5 hours post-challenge]

    Serum tryptase levels (ng/mL) will be quantified with ImmunoCap comparing post-challenge levels with baseline.

  2. Histamine/Methyl-histamine [Serial samples from 0 to 6 hours post-challenge]

    Histamine and methyl-histamine (ng/mL) from serum and urine samples will be quantified with ELISA comparing post-challenge to baseline.

  3. 11Beta-PGF2-alpha [Serial samples from 0 to 6 hours post-challenge]

    11Beta-PGF2-alpha (pg/mL), a PGD2 metabolite, will be quantified in serum and urine with ELISA comparing post-challenge to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeffrey Wilson, MD, Assistant Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier:
NCT04828317
Other Study ID Numbers:
  • HSR200447
First Posted:
Apr 2, 2021
Last Update Posted:
Apr 2, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Food Hypersensitivity

Study Results

No Results Posted as of Apr 2, 2021