NCT03763487

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

October 12, 2018

Last Update Submit

December 3, 2018

Conditions

Celiac Disease

Keywords

celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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)

    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)

    one year

Study Arms (2)

Patients

EXPERIMENTAL

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

Diagnostic Test: venous blood samplingProcedure: spleen volumetry

healthy blood donors

NO INTERVENTION

No intervention in this group.

Interventions

venous blood samplingDIAGNOSTIC_TEST

Venous blood samples to determine memory B lymphocytes.

Patients
spleen volumetryPROCEDURE

Ultrasound examination of spleen to scaled the size.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed celiac disease
  • age over 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Králové

Hradec Králové, The Czech Republic, 500 05, Czechia

RECRUITING

Related Links

MeSH Terms

Conditions

Celiac Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Ladislav Douda, M.D.

CONTACT

495 83 4240ladislav.douda@fnhk.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 50 patients and 30 healthy blood donor
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2018

First Posted

December 4, 2018

Study Start

June 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

CZ(1)