Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis
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
- 是
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
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
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)
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)
Patients with ulcerative colitis in this group will take standart therapy (mesalazin)
干预措施: Mesalazine 250Mg (Drug)
UC patients (cohort 2)
Patients with ulcerative colitis in this group will take placebo tabletes
干预措施: parasitological diagnostics (coproscopy) (Diagnostic Test)
UC patients (cohort 2)
Patients with ulcerative colitis in this group will take placebo tabletes
干预措施: Placebo tabletes (Drug)
UC patients (cohort 3)
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)
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
Svetlana Osipova, MD, PhD, DS
MD, PhD, DS
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
