Clinical trial NCT05277662: Precision Diagnostics of Functional and Organic Intestinal Pathology Based on Cellular and Molecular Profiling
Official title: Biomedical Experimental Study for Precise Diagnostics of Functional and Organic Intestinal Pathology Based on Cellular and Molecular Profiling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Healthy Volunteers
Keywords: Inflammatory Bowel Disease
Crohn's disease
Ulcerative colitis
Irritable Bowel Syndrome
Precision diagnostics
Metabolomics
Genomics
Transcriptomics
Immunology
Lead sponsor: Moscow State University of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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 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

Primary outcomes:
measure: Changes of metabolic profile in patients with functional and organic intestinal diseases
timeFrame: 2 years
measure: Changes in genetic profile in patients with functional and organic intestinal diseases
timeFrame: 2 years
measure: Changes in immunological profile (local) in patients with functional and organic intestinal diseases
timeFrame: 2 years
measure: Changes in immunological profile (systemic) in patients with functional and organic intestinal diseases
timeFrame: 2 years
measure: Changes in functional parameter - RST in patients with functional and organic intestinal diseases
timeFrame: 2 years
measure: Changes in functional parameter - ARM in patients with functional and organic intestinal diseases
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
Study officials:
affiliation: Moscow State University of Medicine and Dentistry
name: Igor Maev, Acad.the RAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Malderen K, De Winter BY, De Man JG, De Schepper HU, Lamote K. Volatomics in inflammatory bowel disease and irritable bowel syndrome. EBioMedicine. 2020 Apr;54:102725. doi: 10.1016/j.ebiom.2020.102725. Epub 2020 Apr 21.
citation: Aziz I, Simren M. The overlap between irritable bowel syndrome and organic gastrointestinal diseases. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):139-148. doi: 10.1016/S2468-1253(20)30212-0. Epub 2020 Nov 13.
citation: Gehart H, Clevers H. Tales from the crypt: new insights into intestinal stem cells. Nat Rev Gastroenterol Hepatol. 2019 Jan;16(1):19-34. doi: 10.1038/s41575-018-0081-y.
citation: Sperber AD, Bangdiwala SI, Drossman DA, Ghoshal UC, Simren M, Tack J, Whitehead WE, Dumitrascu DL, Fang X, Fukudo S, Kellow J, Okeke E, Quigley EMM, Schmulson M, Whorwell P, Archampong T, Adibi P, Andresen V, Benninga MA, Bonaz B, Bor S, Fernandez LB, Choi SC, Corazziari ES, Francisconi C, Hani A, Lazebnik L, Lee YY, Mulak A, Rahman MM, Santos J, Setshedi M, Syam AF, Vanner S, Wong RK, Lopez-Colombo A, Costa V, Dickman R, Kanazawa M, Keshteli AH, Khatun R, Maleki I, Poitras P, Pratap N, Stefanyuk O, Thomson S, Zeevenhooven J, Palsson OS. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. Gastroenterology. 2021 Jan;160(1):99-114.e3. doi: 10.1053/j.gastro.2020.04.014. Epub 2020 Apr 12.
citation: Wilson JC, Furlano RI, Jick SS, Meier CR. Inflammatory Bowel Disease and the Risk of Autoimmune Diseases. J Crohns Colitis. 2016 Feb;10(2):186-93. doi: 10.1093/ecco-jcc/jjv193. Epub 2015 Oct 27.