200
Participants
Start Date
June 1, 2017
Primary Completion Date
June 1, 2020
Study Completion Date
January 1, 2023
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, ...).
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).
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.
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."
Hospital Universitari Mutua Terrassa, Terrassa
Hospital Mutua de Terrassa
OTHER