Celiac DiseaseNCT03763487
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
A study testing venous blood sampling and spleen volumetry in people with Celiac Disease, run by University Hospital Hradec Kralove at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- venous blood sampling and spleen volumetry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed celiac disease
- age over 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Králové
Hradec Králové, The Czech Republic, 500 05
Ladislav Douda, M.D., 495 83 4240, ladislav.douda@fnhk.cz
About this study
Official title: 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
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).
- Conditions
- Celiac Disease
- Being tested
- venous blood sampling, spleen volumetry
- Keywords
- celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous blood samplingDiagnostic test
Venous blood samples to determine memory B lymphocytes.
spleen volumetryProcedure or surgery
Ultrasound examination of spleen to scaled the size.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling Receives: Diagnostic Test: venous blood sampling; Procedure: spleen volumetry |
| healthy blood donors | No intervention | No intervention in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
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
Measured: one year
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)
Measured: one year
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 patients and 30 healthy blood donor
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Proff. Jan Bures, MD, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763487
- Sponsor's protocol ID
- Indicators of celiac activity
- Status last verified
- Dec 2018
- First submitted
- 12 Oct 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Zone Similar to B Lymphocytes in Peripheral Blood in Patients With Celiac Disease
- ClinicalTrials.gov ID
- NCT03763487
- Acronym / sponsor ID
- Indicators of celiac activity
- Conditions
- Celiac Disease
- Keywords
- celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 patients and 30 healthy blood donor
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Diagnostic Test: venous blood sampling, Procedure: spleen volumetryUltrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling |
| healthy blood donors | No intervention | –No intervention in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed celiac disease
- age over 18 years
Key exclusion criteria (7 listed)
- haematological diseases and cancer
- infectious and non-infectious inflammation of the small intestine
- congenital or acquired immunodeficiency
- autoimmune disease
- immunosuppressant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venous blood samplingVenous blood samples to determine memory B lymphocytes. | Diagnostic test | Patients |
| spleen volumetryUltrasound examination of spleen to scaled the size. | Procedure or surgery | Patients |
Primary outcome
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
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
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venous blood sampling and spleen volumetry in people with Celiac Disease, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ladislav Douda, M.D. (495 83 4240, ladislav.douda@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of B-lymphocytes as parameter to evaluate treatment effect (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.