CTRI/2008/091/000086已完成2/3 期
A RANDOMIZED, OPEN LABELLED, CONTROLLED TRIAL OF A PROBIOTIC PREPARATION, VSL#3, FOR ASSESSING CLINICAL AND HISTOLOGICAL RESPONSE IN PATIENTS WITH MICROSCOPIC COLITIS
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical Remission defined as more than 50% reduction in stool frequency or stool weight. Clinical response defined as significant reduction in stool frequency or stool weight
研究概览
简要总结
This is an open label trial to compare the clinical and histological improvement in patients with microscopic colitis on VSL#3 Vs Mesalamine. The duration of treatment will be 8 weeks. Then, thereafter a wash-out period of 2 weeks, patients taking mesalamine will be given VSL#3 for 8 weeks. The patients who were in VSL#3 treatment arm will be off medication and followed up for the next 10 weeks and the diarrheal scores will be noted for relapse. The endpoints would be assessed based on the histological improvement, stool consistency, stool frequency, stool weight, mucus and the QoL score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than or equal to 18 years
- •Collagenous or lymphocytic colitis diagnosed on colon biopsies reviewed by a GI pathologist
- •Currently symptomatic as defined by more than or equal to 3 bowel movements per day with a stool consistency more than 3 and a diarrhea severity score more than 1 averaged over the week prior to enrolment in the study
- •A syndrome present for at least 8 weeks characterized by non-bloody watery diarrhea
- •A normal endoscopic appearance of the colonic mucosa
- •Colonic histopathology (that includes involvement of distal colon) consisting of excess mononuclear inflammatory cells in the lamina propria and surface epithelium without significant neutrophilic or eosinophilic inflammation, numerous crypts abscesses, or granulomata and no other evidence of Crohn?s disease
- •Eligible patients would be included if they had no steatorrhea, had taken no antibiotics or anti-inflammatory agents for at least 6 weeks and no antidiarrheals (e.g., Loperamide) for at least 2 weeks before beginning the study
- •Negative stool culture for pathogens (Salmonella and Shigella), parasites and ova/ cyst
- •For women of child-bearing potential, had a negative pregnancy test
- •Ability to give a valid informed consent.
排除标准
- •Unwilling or unable to give informed consent, follow protocol or to stop all medications used to treat diarrhea or colitis
- •Treatment with immunosuppressive medications or presence of an immunocompromised state
- •Other active diarrheal conditions (sprue, infection, hyperthyroidism)
- •Current infection with enteric pathogen
- •Significant hepatic, renal, endocrine (Diabetes), respiratory, neurological or cardiovascular disease as determined by the principal Investigator
- •Patient requiring hospitalization
- •Pregnancy or lactation
- •Use of any other investigational drug and/or participation in any clinical trial within 3 months of entry to this study.
结局指标
主要结局
Clinical Remission defined as more than 50% reduction in stool frequency or stool weight. Clinical response defined as significant reduction in stool frequency or stool weight
时间窗: 8 and 18 wks
次要结局
- Diarrheal Rate, Stool consistency, Abdominal pain, mucus, well being, Histopathology, immunihistochemical iNOS staining(8 and 18 wks)
研究者
研究点 (1)
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