CClinicalTrials.gg
Status unknownNCT03763487Updated Dec 4, 2018

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

An interventional study of venous blood sampling and spleen volumetry in Celiac Disease, sponsored by University Hospital Hradec Kralove. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-04.

Sponsored by University Hospital Hradec Kralove · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2018, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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).

02

Conditions studied

  • Celiac Disease

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Keywords

  • celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes
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In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 203 interventional studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

University Hospital Hradec Kralove is the lead sponsor of 47 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosed celiac disease
  • age over 18 years

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients

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

    Diagnostic Test: venous blood sampling · Procedure: spleen volumetry

  • No intervention
    healthy blood donors

    No intervention in this group.

Interventions

  • Diagnostic testvenous blood sampling

    Venous blood samples to determine memory B lymphocytes.

  • Procedurespleen volumetry

    Ultrasound examination of spleen to scaled the size.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

  2. 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

    Time frame: one year

  3. 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)

    Time frame: one year

  4. 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)

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • University Hospital Hradec Králové
    Hradec Králové, The Czech Republic 500 05, Czechia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03763487
Lead sponsor
University Hospital Hradec Kralove
Responsible party
Proff. Jan Bures, MD (Principal Investigator, University Hospital Hradec Kralove) — Principal investigator
First posted
Dec 4, 2018
Start date
Jun 1, 2018
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Dec 4, 2018

Study contacts

Ladislav Douda, M.D.
Contact
ladislav.douda@fnhk.cz
495 83 4240

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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