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

Not Applicable
Completed
Conditions
Celiac disease, inflammatory bowel disease (Crohn’s disease and ulcerative colitis)
Digestive System
Coeliac disease, inflammatory bowel disease
Registration Number
ISRCTN49677481
Lead Sponsor
Centre for Translational Medicine
Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30904871 protocol (added 09/04/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33259164/ (added 23/11/2021) 2019 Abstract results in https://onlinelibrary.wiley.com/doi/10.1177/2050640619854671 Abstract P2052; UEG - United European Gastroenterology Week 2019 Poster Presentations (added 11/07/2023)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
212
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

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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