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

NCT ID: NCT03763487

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-12-31

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).

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

50 patients and 30 healthy blood donor
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

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

Group Type EXPERIMENTAL

venous blood sampling

Intervention Type DIAGNOSTIC_TEST

Venous blood samples to determine memory B lymphocytes.

spleen volumetry

Intervention Type PROCEDURE

Ultrasound examination of spleen to scaled the size.

healthy blood donors

No intervention in this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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venous blood sampling

Venous blood samples to determine memory B lymphocytes.

Intervention Type DIAGNOSTIC_TEST

spleen volumetry

Ultrasound examination of spleen to scaled the size.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Hradec Kralove

OTHER

Sponsor Role lead

Responsible Party

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Proff. Jan Bures, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Hradec Králové

Hradec Králové, The Czech Republic, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Ladislav Douda, M.D.

Role: CONTACT

495 83 4240

Facility Contacts

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Ladislav Douda, M.D.

Role: primary

495 83 4240

Related Links

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Other Identifiers

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Indicators of celiac activity

Identifier Type: -

Identifier Source: org_study_id

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