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Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis

NCT03441893 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-03-03

No results posted yet for this study

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 submucosal layers of the colon. The object of the present study was to determine the prevalence of intestinal protozoa and helminthes in UC patients, and the role of this changes in aetiopathogenesis of diseases. Patients will be examined before and after therapy. Parasites and protozoa prevalence and intensity will be detected by triple coproscopy.Microbiological study will be conducted before therapy for detection pathogenic bacteria only from UC patients infected with B. hominis . If intestinal pathogenic bacteria are found, participants will be excluded from further investigation.

Conditions

  • Ulcerative Colitis
  • Ulcerative Colitis Exacerbation
  • Protozoan Infections
  • Helminth Infection

Interventions

DIAGNOSTIC_TEST

parasitological diagnostics (coproscopy)

Three stool samples for parasitological examination will be taken from ulcerative colitis patients at 1-2 days interval.

DRUG

Nitazoxanide 500Mg Oral Tablet

Tab. nitazoxanide by a 1.0 g/day (two pills) twice over orally for 14 consecutive days

DRUG

Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet

Tab. nitazoxanide by a 1.0 g/day (one pill - 500 mg) twice over orally and mesalazine 1.5 g/day (one pill - 500 mg) three times a day orally for 14 consecutive days

DRUG

Mesalazine 250Mg

Tab. mesalazine ≥3 g/day (one pill - 500 mg) three times a day orally for 14 consecutive days

DRUG

Placebo tabletes

Tab. Placebo (shugar pills) will be given to the participants

Sponsors & Collaborators

  • Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2025-07-01
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441893 on ClinicalTrials.gov