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

Last updated: March 11, 2022
Sponsor: Moscow State University of Medicine and Dentistry
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Healthy Volunteers

Treatment

N/A

Clinical Study ID

NCT05277662
CSR-04/21
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 acutecardiovascular 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 incompleteclinical trials (including follow up - the period of observation after completion ofthe study)
  • Any condition which, in the opinion of investigator, makes the patient unsuitable forparticipation in the study

Study Design

Total Participants: 120
Study Start date:
October 01, 2021
Estimated Completion Date:
May 15, 2023

Connect with a study center

  • Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency

    Moscow, 119435
    Russian Federation

    Active - Recruiting

  • Moscow State University of Medicine and Dentistry

    Moscow, 127473
    Russian Federation

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.