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临床试验/NCT03441893
NCT03441893进行中(未招募)1 期

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

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan0 个研究点目标入组 300 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
300
主要终点
Prevalence of Lamblia intestinalis and Cryptosporidium parvum in patients with ulcerative colitis and association with pathogenesis

研究概览

简要总结

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.

详细描述

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 Coloproctology department of the Republic clinical hospital №1, Ministry of Public Health of the Republic of Uzbekistan.

Participants Diagnosis of UC will be confirmed using standard clinical, endoscopic, radiographic, and pathological criteria according to the Montreal classification of extent and severity of ulcerative colitis (Silverberg MS et al. 2006). UC categories include proctitis, left-sided colitis, and extensive colitis or pancolitis. Activity of the disease will be measured by Mayo Clinic score that consists of 4 items: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and patient's functional assessment (D'Haens G et al. 2007). The disease duration will be measured in years from the first time of symptoms onset.

UC patients hospitalized in coloproctology department of Republic clinical hospital №1 will be examined before surgery and receiving of medications. Additional cohort groups: the 1st one will include UC patients infected with B. hominis which will be examined before and after taking nitazoxanide (monotherapy), the 2nd group will include UC patients infected with B. hominis before and after taking nitazoxanide and mesalazine (combination therapy) and 3rd one - patients with UC infected with B. hominis before and after taking mesalazine (monotherapy).

The control group will include residents of Tashkent region without any complaints from the gastrointestinal tract, who will apply to the clinic for planned medical examinations. Suggested age of the population from 17 to 90 years

Exclusion criteria Patients with diagnosis of Crohn's disease will be excluded from the analysis. Other exclusion criteria are toxic megacolon, abdominal abscess, symptomatic colonic stricture, stoma, a history of colectomy, an increased risk of infectious complications (e.g. as a result of recent pyogenic infection, enteric pathogens detected in microbiological stool analysis, active or latent tuberculosis, immunodeficiency, hepatitis B or C, or recent live vaccination), clinically meaningful laboratory abnormalities, pregnancy or lactation, unstable or uncontrolled medical disorders, an anticipated requirements for major surgery, colonic dysplasia or adenomas, and malignant neoplasms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Patients with ulcerative colitis

Active Comparator

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

干预措施: parasitological diagnostics (coproscopy) (Diagnostic Test)

Patients with ulcerative colitis

Active Comparator

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

干预措施: Nitazoxanide 500Mg Oral Tablet (Drug)

UC patients (cohort 1)

Active Comparator

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

干预措施: parasitological diagnostics (coproscopy) (Diagnostic Test)

UC patients (cohort 1)

Active Comparator

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

干预措施: Mesalazine 250Mg (Drug)

UC patients (cohort 2)

Placebo Comparator

Patients with ulcerative colitis in this group will take placebo tabletes

干预措施: parasitological diagnostics (coproscopy) (Diagnostic Test)

UC patients (cohort 2)

Placebo Comparator

Patients with ulcerative colitis in this group will take placebo tabletes

干预措施: Placebo tabletes (Drug)

UC patients (cohort 3)

Active Comparator

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

干预措施: parasitological diagnostics (coproscopy) (Diagnostic Test)

UC patients (cohort 3)

Active Comparator

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

干预措施: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet (Drug)

结局指标

主要结局

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

时间窗: up to 36 months

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

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

时间窗: up to 36 months

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

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

时间窗: up to 24 months

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

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

时间窗: up to 36 months

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

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

时间窗: up to 24 months

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

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

时间窗: up to 24 months

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

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

时间窗: up to 24 months

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

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

时间窗: up to 24 months

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

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

时间窗: up to 24 months

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

次要结局

未报告次要终点

研究者

发起方
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Svetlana Osipova, MD, PhD, DS

MD, PhD, DS

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

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