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

December 3, 2018 updated by: Proff. Jan Bures, MD, University Hospital Hradec Kralove

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • The Czech Republic
      • Hradec Králové, The Czech Republic, Czechia, 500 05
        • Recruiting
        • University Hospital Hradec Kralove
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Indicators of celiac activity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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