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Investigation of laboratory and clinical parameters in the background of thrombosis in celiac disease and inflammatory bowel diseases

Hemorheologic parameters in celiac disease and inflammatory bowel diseases: a prospective controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN49677481
Enrollment
150
Registered
2018-06-29
Start date
2018-05-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac disease, inflammatory bowel disease (Crohn’s 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

Sponsors

Centre for Translational Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: CD patients 1. Newly diagnosed or followed-up patients (with or without adhering to a gluten-free diet (GFD) 2. Aged =18 years 3. Diagnosis should meet the current guidelines (ESPHGAN, American College of Gastroenterology) IBD patients 1. Newly diagnosed and followed-up patients 2. Aged =18 years 3. Diagnosis should meet the current guidelines (ECCO) Non-CD, non-IBD controls 1. Aged =18 years 2. Celiac disease excluded (lack of symptoms and negative celiac-specific serology) 3. IBD excluded (lack of clinical, biochemical, endoscopic or radiologic signs of the disease)

Exclusion criteria

Exclusion criteria: 1. Estimated glomerular filtration rate calculated with CKD-EPI formula <60 ml/min/1.73 m2 (CKD Stage 3 or more severe kidney failure) 2. Liver cirrhosis (Child-Pugh class B/C) 3. Heart failure (NYHA class III/IV) 4. Malignant diseases (except for cured cases) 5. Acute diseases within 2 weeks of sampling 6. Patients unable to understand the essentials of the informed consent

Design outcomes

Primary

MeasureTime frame
Hemorheologic test results including erythrocyte deformability and aggregation and viscosity of whole blood and plasma The measurement of laboratory parameters will be done on the day of recruitment.

Secondary

MeasureTime frame
Risk of arterial and venous thrombosis (determined by clinical and laboratory measures on the day of recruitment)

Countries

Hungary

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 15, 2026