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

NCT03441893 | Unknown Phase 1 DMC

• 1 other identifier: #15.21.2
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

ulcerative colitis, helminths, intestinal protozoan, nitazoxanide

Outcome Measures

Primary Outcomes (9)

• Prevalence of intestinal helminths in patients with ulcerative colitis and association with pathogenesis.

  In this study we expect to find intestinal helminths in patients with ulcerative colitis and determine their role in the development and course of ulcerative colitis

  up to 36 months

• Prevalence of Lamblia intestinalis and Cryptosporidium parvum in patients with ulcerative colitis and association with pathogenesis

  In this study we expect to find pathogenic protozoa in patients with ulcerative colitis and determine their role in the development of ulcerative colitis

  up to 36 months

• Prevalence of intestinal protozoa (commensals) in patients with ulcerative colitis and association with pathogenesis

  In this study we are going to determine their prevalence and role in the development of ulcerative colitis

  up to 36 months

• Efficiency of antiparasitic therapy with nitazoxanide in ulcerative colitis patients infected with B. hominis

  Reduction of intensity or eradication of B. hominis in stool samples of patients with ulcerative colitis

  up to 24 months

• Efficiency of combination therapy with nitazoxanide and mesalazine in ulcerative colitis patients infected with B. hominis

  Reduction of intensity or eradication of B. hominis in stool samples of patients with ulcerative colitis

  up to 24 months

• Efficiency of monotherapy with mesalazine in ulcerative colitis patients infected with B. hominis

  Reduction of intensity or eradication of B. hominis in stool samples of patients with ulcerative colitis

  up to 24 months

• Clinical efficiency of antiparasitic therapy with nitazoxanide in ulcerative colitis patients infected with B. hominis

  A positive/negative clinical response of disease in ulcerative colitis patients

  up to 24 months

• Clinical efficiency of combination therapy with nitazoxanide and mesalazine in ulcerative colitis patients infected with B. hominis

  A positive/negative clinical response of disease in ulcerative colitis patients

  up to 24 months

• Clinical efficiency of monotherapy with mesalazine in ulcerative colitis patients infected with B. hominis

  A positive/negative clinical response of disease in ulcerative colitis patients

  up to 24 months

Study Arms (5)

Patients with ulcerative colitis

ACTIVE COMPARATOR

Patients with ulcerative colitis in this group will take nitazoxanide per os

Diagnostic Test: parasitological diagnostics (coproscopy); Drug: Nitazoxanide 500Mg Oral Tablet

Participants (control group)

NO INTERVENTION

only parasitological diagnostics will be performed in this group to compare the prevalence of some representatives of the microbiota

UC patients (cohort 1)

ACTIVE COMPARATOR

Patients with ulcerative colitis in this group will take standart therapy (mesalazin)

Diagnostic Test: parasitological diagnostics (coproscopy); Drug: Mesalazine 250Mg

UC patients (cohort 2)

PLACEBO COMPARATOR

Patients with ulcerative colitis in this group will take placebo tabletes

Diagnostic Test: parasitological diagnostics (coproscopy); Drug: Placebo tabletes

UC patients (cohort 3)

ACTIVE COMPARATOR

Patients with ulcerative colitis in this group will take combination standart therapy with nitazoxanide

Diagnostic Test: parasitological diagnostics (coproscopy); Drug: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet

Interventions

parasitological diagnostics (coproscopy) DIAGNOSTIC_TEST

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

Patients with ulcerative colitis; UC patients (cohort 1); UC patients (cohort 2); UC patients (cohort 3)

Nitazoxanide 500Mg Oral Tablet DRUG

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

Patients with ulcerative colitis

Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet DRUG

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

UC patients (cohort 3)

Mesalazine 250Mg DRUG

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

UC patients (cohort 1)

Placebo tabletes DRUG

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

UC patients (cohort 2)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ulcerative colitis before therapy and surgery
• Residents of Tashkent region which does not have any complaints from the gastrointestinal tract (control group)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (1)

• Toychiev A, Navruzov B, Pazylova D, Davis N, Badalova N, Osipova S. Intestinal protozoa and helminths in ulcerative colitis and the influence of anti-parasitic therapy on the course of the disease. Acta Trop. 2021 Jan;213:105755. doi: 10.1016/j.actatropica.2020.105755. Epub 2020 Nov 11.

  PMID: 33188747 RESULT

Related Links

• Article in Pubmed

MeSH Terms

Conditions

Colitis, Ulcerative; Protozoan Infections; Trematode Infections

Interventions

nitazoxanide; Tablets; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Parasitic Diseases; Infections; Helminthiasis

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DS

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 22, 2018
• Study Start: January 1, 2015
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 3, 2023

Record last verified: 2023-03