Histopathologic and Lymphocyte Subpopulations Evaluation of the Upper Gastrointestinal Tract of Crohn's Disease

CompletedOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

June 1, 2020

Study Completion Date

January 1, 2023

Conditions
Crohn Disease
Interventions
BEHAVIORAL

General variables

Variables evaluated: age, sex, location, extent, and phenotype of IBD according to the Montreal classification, smoking habit, therapeutic requirements (immunosuppressants, biologics, steroids, salicylates, drugs that cause enteropathy such as olmesartan, valsartan, non-steroidal anti-inflammatory drugs, etc, ...).

BEHAVIORAL

Clinical activity

Clinical activity was evaluated using the Harvey-Bradshaw index (HBI) (cut-off values: \<5, remission; 5-7, mild activity; 8-16, moderate activity; and \>16, severe activity).

PROCEDURE

Laboratory data

Laboratory data: blood count, renal function and C-reactive protein, anti-transglutaminase antibodies, genetic study of celiac disease DQ2.5, DQ8, and DQ2.2, study of parasites, fecal calprotectin.

PROCEDURE

Endoscopic and histology data

"Endoscopic signs suggestive of CD in UDT (presence of canker sores, ulcers, ...) and colon inflammatory activity was evaluated when available in patients with active disease using the Simple Endoscopic Score for CD (SES-CD: 0-2, remission; 3-6, mild endoscopic activity; 7-15, moderate endoscopic activity; and \>15, severe endoscopic activity).~Duodenal biopsies were assessed by 2 pathologists and were evaluated according to Marsh classification modified by Ensari \[Marsh 0, 1, 2 or 3\], the limit of normality for intraepithelial lymphocytes (IELs) per 100 enterocytes is set at 25, gastric biopsies (determination of H. Pylori by immunohistochemistry) and esophageal biopsies was recorded too.~Percentage of lymphocyte subpopulations are assessed by flow cytometry."

Trial Locations (1)

08221

Hospital Universitari Mutua Terrassa, Terrassa

All Listed Sponsors
lead

Hospital Mutua de Terrassa

OTHER

NCT05874349 - Histopathologic and Lymphocyte Subpopulations Evaluation of the Upper Gastrointestinal Tract of Crohn's Disease | Biotech Hunter | Biotech Hunter