Condition category
Digestive System
Date applied
05/03/2018
Date assigned
29/06/2018
Last edited
29/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Celiac disease (CD) or gluten-sensitive enteropathy is a immune system disorder affecting 1% of the Western population, while inflammatory bowel disease (IBD) is less common. Hypercoagulability (an increased tendency for the blood to clot) is associated with several immune-mediated disorders, including CD and IBD. The aim of this study is to assess the properties of blood and blood flow in CD and IBD patients compasred with people without these diseases to understand whether having CD or IBD means people are more likely to have problems involving blood clots..

Who can participate?
We will include CD patients, IBD patients, and non-CD, non-IBD volunteers. Adults (≥18 years) will be included irrespective of gender.

What does the study involve?
Participants will give blood and urine samples, fill in questionnaires and be interviewed by researchers.

What are the possible benefits and risks of participating?
This is an observational study, which means there is no treatment given. The study involves assessing the normal situation. Only those patients where blood tests have already been ordered for medical reasons (e.g., at a follow-up visit or for diagnostic purposes) will be included. Patients may benefit from the results of detailed laboratory investigations and dietary assessment. Due to the observational design of the study, there will be no side effects.

When is the study starting and how long is it expected to run for?
March 2018 to December 2019

Who is funding the study?
No financial compensation will be given to the participants and there is no extra cost to them. Since no additional treatment is necessary for the study, the general healthcare costs are covered by the National Healthcare System (University of Pécs – Medical School). Center costs and the cost of the study are funded by the following grants: University of Pécs Medical School, Momentum Grant of the Hungarian Academy of Sciences (LP2014-10/2014), Highly Cited Publication Grant (KH 125678) of the National Research Development and Innovation Office (GINOP 2.3.2-15-2016-00048 Stay Alive) and (EFOP 3.6.2-16-2017-00006 Live Longer), and Translational Medicine Foundation. In addition, this project is supported by the ÚNKP-17-3-II New National Excellence Program of the Ministry of Human Capacities.

Who is the main contact?
Peter Hegyi, hegyi.peter@med.u-szeged.hu

Trial website

Contact information

Type

Scientific

Primary contact

Prof Péter Hegyi

ORCID ID

Contact details

12 Szigeti Street
Pécs
7624
Hungary
0036703751031
hegyi.peter@med.u-szeged.hu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

HERMES

Study hypothesis

Hemorheologic alterations may be responsible for the increased risk of thrombosis in celiac (CD) and inflammatory bowel disease (IBD) patients.

Ethics approval

University of Pécs Regional and Local Research Ethics Committee, 08/12/2017, 6917

Study design

Prospective controlled cross-sectional trial

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Patient information material will be available from: www.tm-centre.org

Condition

Celiac disease, inflammatory bowel disease (Crohn’s disease and ulcerative colitis)

Intervention

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) will be stored in the Biobank of Institute for Translational Medicine, University of Pécs at -80°C.
3. Mid-stream urine will be collected and stored at -80°C until processing. After preparation (centrifugation, solid-phase extraction, lyophilisation), gluten immunogenic peptides will be detected by commercial ELISA (Biomedal, Spain).

Intervention type

Not Specified

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/03/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

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), then an interim analysis will be performed. Further recruitment will be arranged by the power of comparisons of hemorheologic test results of CD and control and IBD vs. control patients.

Participant 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

Recruitment start date

01/05/2018

Recruitment end date

31/05/2019

Locations

Countries of recruitment

Hungary

Trial participating centre

Division of Gastroenterology, 1st Department of Internal Medicine, University of Pécs
Ifjúság Str.
Pécs
7624
Hungary

Sponsor information

Organisation

Cenre for Translational Medicine

Sponsor details

12 Szigeti Street
Pécs
7624
Hungary
0072533100
hegyi.peter@med.u-szeged.hu

Sponsor type

Research organisation

Website

https://tm-centre.org

Funders

Funder type

Government

Funder name

This project is supported BY the ÚNKP-17-3-II New National Excellence Program of the Ministry of Human Capacities and by Hungarian Academy of Sciences (Momentum Grant)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes