Biomedical Experimental Study for Precise Diagnostics of Functional and Organic Intestinal Pathology Based on Cellular and Molecular Profiling
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Changes of metabolic profile in patients with functional and organic intestinal diseases
研究概览
简要总结
Differential diagnosis of functional and organic intestinal pathology is carried out in line with approved clinical guidelines and includes a significant list of interventions. However, considering the possibility of an "overlap" between functional and organic diseases, as well as the non-specificity of a number of assessment parameters, it is advisably to define new diagnostic approaches and reliable cell and molecular markers, that will update and ensure the precision diagnostics of intestinal diseases. The integrative functional, cell and molecular markers will create the basis and possibilities for the personalized selection of patient therapy.
The study is intended to develop the methods of precision diagnostics based on cellular-molecular profiling with an assessment of functional parameters of the intestine in functional and organic intestinal diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Gender: Male or Female
- •Age: 18-70 years old
- •Clinically, laboratory and/or endoscopically confirmed diagnosis of functional (Irritable Bowel Syndrome) and organic (Crohn's Disease, Ulcerative Colitis) intestinal disease
- •Healthy volunteers
排除标准
- •Age under 18 or over 70;
- •Acute intestinal infections;
- •Antibiotic-associated intestinal lesions;
- •Tuberculosis of the intestine;
- •Systemic vasculitis;
- •Oncological diseases;
- •Diverticulitis;
- •Solitary rectal ulcer;
- •Ischemic colitis;
- •Syndrome of bacterial overgrowth;
- •Decompensation of chronic diseases of the cardiovascular system or acute cardiovascular diseases;
- •Acute or exacerbation of chronic respiratory diseases, respiratory failure;
- •Acute infectious diseases;
- •Diabetes mellitus;
- •Disorders of the blood coagulation system;
- •Mental disorders
- •Female patients who are pregnant, planning to become pregnant or lactating
- •Participation in a clinical trial in the past 3 months and in any other incomplete clinical trials (including follow up - the period of observation after completion of the study)
- •Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study
结局指标
主要结局
Changes of metabolic profile in patients with functional and organic intestinal diseases
时间窗: 2 years
Assessment of metabolome ( gas chromatographic analysis with vapor-phase extraction). Metabolic parameters (Tetradecanoic acid, Hydracinnamic acid, Hexadecanoic acid, Hexanoic acid, Indole, Pentanoic acid) will be measured in feces by gas chromatographic analysis with vapor-phase extraction method. Metabolite extraction methods are performed according to the standard metabolite isolation protocol.The above mentioned metabolites will be measured in intensity of the ion current of the analyzed metabolite, normalized to the total ion current according to the standardized methods.
Changes in immunological profile (systemic) in patients with functional and organic intestinal diseases
时间窗: 2 years
Assessment of systemic cytokine profile by Human Cytokine Screening panel Bio-plex Pro (27 cytokines, concentrations measured in pg/ml). Systemic cytokine profile will be assessed by serum analysis. All cytokine concentrations will be measured in pg/ml.
Changes in genetic profile in patients with functional and organic intestinal diseases
时间窗: 2 years
Assessment of genetic profiling (risk polymorphism assessment). Assessment of risk polymorphisms: NOD2 (rs2066844, rs2066845, rs17221417), ATG16L1 (rs2241880), IL23R (rs2201841) will be performed in leukocyte fraction of blood samples according to the standardized methods. Resulting relative risk will be assessed according to the data on relative risks for each of the above mentioned polymorphisms.
Changes in immunological profile (local) in patients with functional and organic intestinal diseases
时间窗: 2 years
Assessment of local cytokine profile by Human Cytokine Screening panel Bio-plex Pro (27 cytokines, concentrations measured in pg/ml). Local cytokine profile will be assessed in gut biopsy lyophilisate. All cytokine concentrations will be measured in pg/ml.
Changes in functional parameter - ARM in patients with functional and organic intestinal diseases
时间窗: 2 years
Instrumental assessment of ARM during functional examination. The procedure is performed according to standardized IAPWG manometry protocol (2020). The measurement will be performed in mmHg.
Changes in functional parameter - RST in patients with functional and organic intestinal diseases
时间窗: 2 years
Instrumental assessment of RST during functional examination. This is the procedure that assesses rectal sensitivity to distension utilizing the balloon attached to the catheter tip. The procedure is performed according to standardized IAPWG manometry protocol (2020). The measurement will be performed in mls. Quantitative measurement of balloon volume is recorded for each of the three patient-reported sensory thresholds: first constant sensation volume (FCSV), desire to defecate volume (DDV) and maximum tolerated volume (MTV).
次要结局
未报告次要终点