The Aim of This Project is to Verify Whether a Depletion of B Cell Memory Subpopulation ("Marginal-zone-like") CD19 + IgD + CD27 + and CD19 + IgM + CD27 + is a Useful Indicator of Hyposplenism in Patients With Celiac Disease

Not Applicable

• Conditions: Celiac Disease
• Interventions: Diagnostic Test: venous blood sampling; Procedure: spleen volumetry

• Registration Number: NCT03763487
• Lead Sponsor: University Hospital Hradec Kralove

Brief Summary

This project is expected to confirm the hypothesis that hyposplenism in patients with celiac disease is not conditioned by a selective memory deficiency of B lymphocytes.

Other objectives of project are:

* determination of gliadin 33-mer in faecal and urine as indicators patient´s adherence to gluten-free diet

* determination of citrulline in plasma as an indicator of the overall functional capacity enterocytes

Detailed Description

Ultrasound examination is focused to spleen size (spleen volumetry). Methodology of laboratory examinations is based on venous blood sampling for the determination of memory B-like marginal zone by flow cytometry; gliadin 33-mer (ELISA) determination in faecal and urine sample; blood plasma extraction for citrulline (high performance liquid chromatography, HPLC).

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-10-12
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-04
• Last Update Posted: 2018-12-04
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• diagnosed celiac disease
• age over 18 years

Exclusion Criteria

• haematological diseases and cancer
• infectious and non-infectious inflammation of the small intestine
• congenital or acquired immunodeficiency
• autoimmune disease
• immunosuppressant treatment
• diabetes mellitus
• pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	venous blood sampling	Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling
Patients	spleen volumetry	Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling

Primary Outcome Measures

Name	Time	Method
concentration of B-lymphocytes as parameter to evaluate treatment effect	one year	assessment method: blood sampling, units: the measurement results are in percentage numbers, method: flow cytometry
concentration of citrullin in plasma as parameter to evaluate treatment effect	one year	assessment method: blood sampling, units: μmol/l (micromol/l; Citrullin cut-off for intestinal failure is \<20μmol / L), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)
concentration of ornithin in plasma as parameter to evaluate treatment effect	one year	assessment method: blood sampling, units: μmol/l (micromol/l), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)

Trial Locations

Locations (1)

University Hospital Hradec Králové; 🇨🇿 Hradec Králové, The Czech Republic, Czechia