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

University Hospital Hradec Kralove

Status: Unknown

Conditions: Celiac Disease

Treatments: Diagnostic Test: venous blood sampling; Procedure: spleen volumetry

Study type: Interventional

Funder types: Other

Identifiers

NCT03763487

Indicators of celiac activity

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Patients

Experimental group

Description:

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

Treatment:

Diagnostic Test: venous blood sampling

Procedure: spleen volumetry

healthy blood donors

No Intervention group

Description:

No intervention in this group.