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
Primary Purpose
Celiac Disease
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
venous blood sampling
spleen volumetry
Sponsored by
About this trial
This is an interventional diagnostic trial for Celiac Disease focused on measuring celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes
Eligibility Criteria
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
Sites / Locations
- University Hospital Hradec KrálovéRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patients
healthy blood donors
Arm Description
Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling
No intervention in this group.
Outcomes
Primary Outcome Measures
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
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
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)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03763487
First Posted
October 12, 2018
Last Updated
December 3, 2018
Sponsor
University Hospital Hradec Kralove
1. Study Identification
Unique Protocol Identification Number
NCT03763487
Brief Title
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
Official Title
Marginal Zone Similar to B Lymphocytes in Peripheral Blood in Patients With Celiac Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
50 patients and 30 healthy blood donor
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling
Arm Title
healthy blood donors
Arm Type
No Intervention
Arm Description
No intervention in this group.
Intervention Type
Diagnostic Test
Intervention Name(s)
venous blood sampling
Intervention Description
Venous blood samples to determine memory B lymphocytes.
Intervention Type
Procedure
Intervention Name(s)
spleen volumetry
Intervention Description
Ultrasound examination of spleen to scaled the size.
Primary Outcome Measure Information:
Title
concentration of B-lymphocytes as parameter to evaluate treatment effect
Description
assessment method: blood sampling, units: the measurement results are in absolute numbers, method: flow cytometry
Time Frame
one year
Title
concentration of B-lymphocytes as parameter to evaluate treatment effect
Description
assessment method: blood sampling, units: the measurement results are in percentage numbers, method: flow cytometry
Time Frame
one year
Title
concentration of citrullin in plasma as parameter to evaluate treatment effect
Description
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
Title
concentration of ornithin in plasma as parameter to evaluate treatment effect
Description
assessment method: blood sampling, units: μmol/l (micromol/l), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ladislav Douda, M.D.
Phone
495 83 4240
Email
ladislav.douda@fnhk.cz
Facility Information:
Facility Name
University Hospital Hradec Králové
City
Hradec Králové
State/Province
The Czech Republic
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ladislav Douda, M.D.
Phone
495 83 4240
Email
ladislav.douda@fnhk.cz
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1419299/
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/18270242
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5415212/
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/11113071
Description
Related Info
Learn more about this trial
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
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