Understanding Gastrointestinal Alpha-Gal Syndrome: (GI Alpha-Gal Study)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• The subject is at least 18 years of age.

• The subject has a history of gastrointestinal alpha-gal allergy defined by elevated test for α-gal allergy (α-gal IgE \>0.1 U/L) due to complaints of either abdominal pain or discomfort, diarrhea, nausea with or without vomiting, or a combination of those complaints, within the last 5 years. The subjects must have experienced one or more of the four symptoms at least once monthly for at least two months. The subjects will fill out a symptom questionnaire of the presence of these four symptoms (abdominal pain or discomfort, diarrhea, nausea, vomiting), frequency and severity (mild, moderate, or severe) for the 3 months prior to diagnosis.

• The subject has experienced symptomatic improvement on a mammalian meat-free diet over at least a month's time, defined by saying yes to the following question: On the alpha-gal avoidant diet, have you had adequate relief of gastrointestinal symptoms?

• The subject has elevated α-gal IgE titer on screening for the trial if they do not have a positive titer within 6 months of enrollment.

• The subject is willing to not take nonsteroidal anti-inflammatory medications, leukotriene modifiers or steroids 14 days prior to challenge.

• The subject is willing to sign the informed consent form.

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Sarah McGill, MD
mcgills@email.unc.edu
+1 (919) 966-7047
Backup
Shilpa Karanjit, MPH
Shilpa_Karanjit@med.unc.edu
919-843-8519
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2026-06-02
Participants
Target number of participants: 30
Treatments
Active_comparator: Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugar
Participants receive a food challenge, consuming pork meat that contains alpha-gal. After a \>10-day washout period, participants undergo a food challenge with pork which does not contain alpha-gal.
Active_comparator: Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal
Participants receive a food challenge consuming pork meat that does not contain alpha-gal sugar. After a \>10-day washout period, participants undergo a food challenge with pork which does contain alpha-gal.
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: Revivicor, Inc

This content was sourced from clinicaltrials.gov