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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Marginal Zone Similar to B Lymphocytes in Peripheral Blood in Patients With Celiac Disease

Conditions
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Celiac Disease

Intervention / Treatment
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* Diagnostic Test: venous blood sampling
* Procedure: spleen volumetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 50 patients and 30 healthy blood donor
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling | Diagnostic Test: venous blood sampling<br>* Venous blood samples to determine memory B lymphocytes.<br>Procedure: spleen volumetry<br>* Ultrasound examination of spleen to scaled the size.<br>|
| No Intervention: healthy blood donors<br>No intervention in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of B-lymphocytes as parameter to evaluate treatment effect | assessment method: blood sampling, units: the measurement results are in absolute numbers, method: flow cytometry | one year | 
| concentration of B-lymphocytes as parameter to evaluate treatment effect | assessment method: blood sampling, units: the measurement results are in percentage numbers, method: flow cytometry | one year | 
| concentration of citrullin in plasma as parameter to evaluate treatment effect | 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) | one year | 
| concentration of ornithin in plasma as parameter to evaluate treatment effect | assessment method: blood sampling, units: μmol/l (micromol/l), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard) | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes