NCT00951548已完成不适用
Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study
VSL Pharmaceuticals26 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 26
- 主要终点
- The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more
研究概览
简要总结
This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis.
详细描述
Title:
Food supplementation with the probiotic preparation VSL#3 as a support to standard pharmaceutical therapy in patient with mild to moderate active Ulcerative Colitis. A double-blind, randomized, placebo controlled study.
Study Design:
Double blind, randomised, parallel groups, placebo controlled, multicentre, national study.
Study Period:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged more than 18 years;
- •Diagnosis of ulcerative colitis established by previous colonoscopy, with consistent histology and clinical course;
- •Ulcerative colitis extending for more than 15 cm from the anal verge, that is involving at least the rectosigmoid. This is based on colonoscopy at any time since the onset of ulcerative colitis. Activity (not extent) must be confirmed by colonoscopy at the beginning of the study;
- •Mild to moderate active ulcerative colitis. Patients must have a minimum score of 3 and a maximum score of 8 on the 12 point UCDAI (Ulcerative Colitis Disease Activity Index - see Appendix 3) that measures stool frequency, rectal bleeding, endoscopic findings and physician's overall assessment of disease severity;
- •Symptomatic (current episode) for less than 4 weeks;
- •Minimum endoscopic score of 2 on the UCDAI at screening (mucosal appearance);
- •Use of oral 5-ASA at least 4 weeks prior to study entry, at same dose; and/or use of Azathioprine or 6-mercaptopurine at least 3 months prior to study entry, at same dose;
- •Negative pregnancy test on screening and agreeing to use valid contraception for the duration of the study;
- •Patient not requiring hospitalisation;
- •Willing an able to provide written informed consent
排除标准
- •Crohn's disease or pouchitis;
- •UCDAI greater than 8 (need for emergency surgery or presence of severe disease;
- •Use of oral steroids within the last 4 weeks prior to study entry;
- •Use of antibiotics within the last 2 weeks prior to study entry;
- •Change in dose of oral 5-ASA within the last 4 weeks prior to study entry and throughout the 8 week study period, or change in dose of oral 6-mercaptopurine and azathioprine drugs within the last 3 months prior to study entry and throughout the 8 week study period;
- •Use of rectal 5-ASA or steroids for one week before and throughout the 8 week study period;
- •Use of probiotic preparations either prescribed or over-the-counter within 2 weeks prior to study entry;
- •Use of NSAIDS for one week before and throughout the 8 week study period;
- •Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the Investigator;
- •History of severe adverse reaction or known hypersensitivity to maltose and/or silicon dioxide;
- •Patient requiring hospitalisation;
- •Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control (negative pregnancy test also required);
- •Use of any investigational drug and/or participation in any clinical trial within 3 months of entry to this study;
- •Inability to give a valid informed consent or to properly follow the protocol
结局指标
主要结局
The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more
时间窗: 8 weeks
次要结局
- Activity of ulcerative colitis(8 weeks)
- Change in subjective symptoms from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3(8 weeks)
- Inability to stay on study(8 weeks)
- Lack of beneficial effects, defined by need for further food supplementation(8 weeks)
研究者
研究点 (26)
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