Trial Details

Not Recruiting
Basic Information
Clinical ID c2752
Identifier ISRCTN49677481
Trial Title Hemorheologic parameters in celiac disease and inflammatory bowel diseases: a prospective controlled study
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Celiac disease, inflammatory bowel disease (Crohn disease and ulcerative colitis) Digestive System Coeliac disease, inflammatory bowel disease
Interventions We will include 50 CD patients, 50 IBD patients, and 50 non-celiac, non-IBD control subjects (age- and sex-matched inclusion after recruiting CD and IBD patients) in the first phase of the study. Then, an interim analysis will be performed to assess power and establish the need for further recruitment. Questionnaires, interviews, urine collection, and blood sampling will be carried out on the day of recruitment. 1. Questionnaires will be applied, as follows: a thrombophilia questionnaire (assessing risk factors and history of venous and arterial thrombotic events) to all participants, Gastrointestinal Symptoms Rating Scale (GSRS) and self-reported dietary adherence (on a scale between 1 and 10 and following the work of Silvester published in 2016 in J Hum Nutr Diet) to CD patients, and Mayo score/Crohn's Disease Activity Index to IBD patients. 2. Venous blood samples will be collected to measure routine laboratory parameters (bilirubin, urea, creatinine, cholesterol (total, high-density and low-density lipoproteins), triglyceride, aspartate- aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total protein, albumin, immunoglobulins, C-reactive protein, vitamin B12, prothrombin, thrombin time, activated partial thromboplastin time, fibrinogen, blood counts, erythrocyte sedimentation, antithrombin activity, protein C activity, protein S activity, antiphospholipid antibodies (lupus anticoagulans, cardiolipin IgG/A/M, B2-glycoprotein-I IgG/A/M, prothrombin IgG/A/M), celiac specific antibodies (tissue transglutaminase IgA/G, gliadin IgA, endomysium IgA)) and hemorheologic tests (erythrocyte aggregation and deformability, viscosity of whole blood and plasma). After preparation, remaining samples (whole blood and plasma) wil
Participant Information
Sponsor Centre for Translational Medicine
City -
Country/Region Hungary
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2020-10-01