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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 March 2023
• Main ID: NCT03441893
• Date of registration: 08/02/2018
• Prospective Registration: No
• Primary sponsor: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
• Public title: Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis
• Scientific title: Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis
• Date of first enrolment: January 1, 2015
• Target sample size: 300
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03441893
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1/Phase 2

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Helminth Infection

Ulcerative Colitis Exacerbation

Protozoan Infections

Intervention(s)

Diagnostic Test: parasitological diagnostics (coproscopy)

Drug: Mesalazine 250Mg

Drug: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet

Drug: Placebo tabletes

Drug: Nitazoxanide 500Mg Oral Tablet

Primary Outcome(s)

Efficiency of monotherapy with mesalazine in ulcerative colitis patients infected with B. hominis [Time Frame: up to 24 months]

Clinical efficiency of monotherapy with mesalazine in ulcerative colitis patients infected with B. hominis [Time Frame: up to 24 months]

Clinical efficiency of antiparasitic therapy with nitazoxanide in ulcerative colitis patients infected with B. hominis [Time Frame: up to 24 months]

Clinical efficiency of combination therapy with nitazoxanide and mesalazine in ulcerative colitis patients infected with B. hominis [Time Frame: up to 24 months]

Efficiency of combination therapy with nitazoxanide and mesalazine in ulcerative colitis patients infected with B. hominis [Time Frame: up to 24 months]

Prevalence of intestinal helminths in patients with ulcerative colitis and association with pathogenesis. [Time Frame: up to 36 months]

Prevalence of Lamblia intestinalis and Cryptosporidium parvum in patients with ulcerative colitis and association with pathogenesis [Time Frame: up to 36 months]

Efficiency of antiparasitic therapy with nitazoxanide in ulcerative colitis patients infected with B. hominis [Time Frame: up to 24 months]

Prevalence of intestinal protozoa (commensals) in patients with ulcerative colitis and association with pathogenesis [Time Frame: up to 36 months]

Secondary ID(s)

#15.21.2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors