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

Celiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03763487
• Other study ID #: Indicators of celiac activity
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2018
• Source: University Hospital Hradec Kralove
• Contact: Ladislav Douda, M.D.
• Phone: 495 83 4240
• Email: ladislav.douda[@]fnhk.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Diagnostic Test:
• venous blood sampling
Venous blood samples to determine memory B lymphocytes.

Procedure:
• spleen volumetry
Ultrasound examination of spleen to scaled the size.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Králové	Hradec Králové	The Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

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