GI Alpha-Gal Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06268717
Status
Recruiting
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Conditions

  • Abdominal Pain
  • Alpha-Gal Syndrome
  • Diarrhea
  • Irritable Bowel Syndrome
  • Vomiting

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ground pork containing alpha-gal — OTHER
    150 grams of cooked, ground pork meat containing alpha-gal sugar eaten once
  • Pork meat not containing alpha-gal — OTHER
    150 grams of cooked, ground pork meat not containing alpha-gal sugar

Study Details

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.

Key Dates

Start date
Oct 17, 2023
Status verified
Oct 2025
Primary completion
Jun 2, 2026
Completion
Jun 2, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Allergic reaction (food challenge positive) [ Time Frame: 6 hours post ingestion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Sarah McGill, MD
[email protected]
919-966-7047
Sarah McGill, MD (PRINCIPAL_INVESTIGATOR)

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