Marginal Zone Similar to B Lymphocytes in Peripheral Blood in Patients With Celiac Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- concentration of citrullin in plasma as parameter to evaluate treatment effect
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed celiac disease
- •age over 18 years
排除标准
- •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
研究组 & 干预措施
Patients
Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling
干预措施: venous blood sampling (Diagnostic Test)
Patients
Ultrasound examination: scaled to spleen size (spleen volumetry) Methodology of laboratory tests: venous blood sampling
干预措施: spleen volumetry (Procedure)
healthy blood donors
No intervention in this group.
结局指标
主要结局
concentration of citrullin in plasma as parameter to evaluate treatment effect
时间窗: 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
时间窗: one year
assessment method: blood sampling, units: μmol/l (micromol/l), method: mass spectrometry (LC-MS instrumentation with internal isotopically labeled standard)
concentration of B-lymphocytes as parameter to evaluate treatment effect
时间窗: one year
assessment method: blood sampling, units: the measurement results are in absolute numbers, method: flow cytometry
次要结局
未报告次要终点
研究者
Proff. Jan Bures, MD
Principal Investigator
University Hospital Hradec Kralove