Evaluate Established Anti-DEFA5 mAbs Diagnostic Efficacy and Safety in IBD

UnknownOBSERVATIONAL
Enrollment

230

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

June 30, 2025

Conditions
Inflammatory Bowel DiseasesUlcerative ColitisCrohn ColitisIndeterminate Colitis
Interventions
DIAGNOSTIC_TEST

Diagnostic Test

30% of IBD patients are misdiagnosed. This affects surgical care of patients. Investigators have unveiled a signature discriminator between UC\&CC that also predicts the outcome of IC patients into authentic UC/CC. This is a bioassay that is specific, sensitive, linear, affordable, minimal risk, non-invasive and constitutes an inexpensive, simple to use, point-of-care test format. Investigators published data which have shown robust presence of DEFA5 in the colon crypt mucosa with aberrant expression of apparent crypt-cell-like cells (CCLCs) in areas identified with ectopic colon ileal metaplasia consistent with CC. Investigators propose to validate that UC/CC, the two unsolved medical sub-types of pathology can accurately be distinguished among IC patients by examining CCLCs secreted DEFA5 levels in endoscopy biopsies instantly. Diagnostics relies on the expression/localization/activation of DEFA5 and the ectopic CCLCs in the mucosal crypt of CC patients.

Trial Locations (1)

37208-3501

Meharry Medical College, Nashville

Sponsors
All Listed Sponsors
lead

Meharry Medical College

OTHER