Status:
UNKNOWN
Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis
Lead Sponsor:
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Conditions:
Ulcerative Colitis
Ulcerative Colitis Exacerbation
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
Brief Summary
Ulcerative colitis (UC) is a chronic inflammatory disorder of the gastrointestinal tract of unknown etiology. UC is characterized by recurring episodes of inflammation limited to mucosal and submucosa...
Detailed Description
The prospective cohort and randomized, double-blind, placebo controlled study will be conducted on the basis of Research Institute of Epidemiology, Microbiology and Infectious Diseases and Coloproctol...
Eligibility Criteria
Inclusion
- Patients with ulcerative colitis before therapy and surgery
- Residents of Tashkent region which does not have any complaints from the gastrointestinal tract (control group)
Exclusion
- Patients with a diagnosis of Crohn's disease
- Patients with a toxic megacolon,
- Patients with a abdominal abscess, -
- Patients with a symptomatic colonic stricture,
- Patients with a stoma,
- Patients with a a history of colectomy,
- An increased risk of infectious complications (e.g. as a result of recent pyogenic infection, enteric pathogens detected on stool analysis, active or latent tuberculosis, immunodeficiency, hepatitis B or C, or recent live vaccination),
- Clinically meaningful laboratory abnormalities,
- Pregnancy or lactation,
- An unstable or uncontrolled medical disorder,
- An anticipated requirement for major surgery,
- Colonic dysplasia or adenomas,
- Malignant neoplasms.
- Patients which operated,
- Ever used immunosuppressants or biological drugs
- In the presence of pathologic bacteria in gut microbiota, including Clostridium difficile, Salmonella spp, Shigella spp, Campylobacter spp, Yersinia spp, and Mycobacteria.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03441893
Start Date
January 1 2015
End Date
December 31 2025
Last Update
March 3 2023
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