Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268717
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-12
Brief Title:
GI Alpha-Gal Study
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Understanding Gastrointestinal Alpha-Gal Syndrome GI Alpha-Gal Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges One food challenge will contain pork meat with alpha gal sugar one challenge will contain pork meat without the alpha gal sugar During the challenges participants will drink lactulose and C13 mannitol dissolved in water The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study The metabolic kitchen and a delegated research staff member will be unblinded
On consenting patients a transnasal upper endoscopy TNE will be performed on each challenge day pre-challenge at hour 0 and post-challenge at hour 6 During the TNE esophagus stomach and small bowel samples will be collected Gastrointestinal pathology samples will be evaluated for inflammatory cells and also biobanked for further messenger RNA mRNA sequencing studies
Blood and urine will be collected during each challenge Samples will be transported to a lab and analyzed for tryptase basophil activation and lactulose mannitol levels
On consenting patients a transnasal upper endoscopy TNE will be performed on each challenge day pre-challenge at hour 0 and post-challenge at hour 6 During the TNE esophagus stomach and small bowel samples will be collected Gastrointestinal pathology samples will be evaluated for inflammatory cells and also biobanked for further messenger RNA mRNA sequencing studies
Blood and urine will be collected during each challenge Samples will be transported to a lab and analyzed for tryptase basophil activation and lactulose mannitol levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None