Precision Diagnostics of Functional and Organic Intestinal Pathology Based on Cellular and Molecular Profiling

Moscow State University of Medicine and Dentistry

Status: Unknown

Conditions: Irritable Bowel Syndrome; Healthy Volunteers; Inflammatory Bowel Diseases

Treatments: Diagnostic Test: cell and molecular diagnostics in accordance with functional test results

Study type: Interventional

Funder types: Other

Identifiers

NCT05277662

CSR-04/21

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Precision diagnostics profiling

Experimental group

Description:

The study will involve subjects with endoscopically, laboratory and clinically confirmed diagnoses of organic and functional intestinal pathology or none of the above (healthy volunteers). All diagnoses are defined in accordance with the validated criteria presented in the clinical guidelines for the diagnosis and treatment of functional bowel pathology (Irritable Bowel Syndrome), 2020, Crohn's Disease (approved by the Ministry of Health of the Russian Federation, 2020), Ulcerative Colitis (approved by the Ministry of Health of the Russian Federation, 2020), in accordance with international criteria of ECCO-ESGAR Guidelines, 2018, 2019. After the initial screening and inclusion in the study, intestinal biopsy samples are taken in accordance with the applied endoscopic examination technique during the endoscopic examination. These biopsy samples will be further used for molecular and immunological diagnostics.

Treatment:

Diagnostic Test: cell and molecular diagnostics in accordance with functional test results