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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03763487

Enrollment

Registered

2018-12-04

Start date

2018-06-01

Completion date

2018-12-31

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes

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).

Interventions

DIAGNOSTIC_TESTvenous blood sampling

Venous blood samples to determine memory B lymphocytes.

PROCEDUREspleen volumetry

Ultrasound examination of spleen to scaled the size.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

50 patients and 30 healthy blood donor

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
concentration of B-lymphocytes as parameter to evaluate treatment effect	one year	assessment method: blood sampling, units: the measurement results are in absolute 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)

Countries

Czechia

Contacts

Primary ContactLadislav Douda, M.D.

ladislav.douda@fnhk.cz495 83 4240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026