ISRCTN31320381已完成2 期
Assessment of a multistrain probiotic (symprove) as a dietary supplement in patients with inflammatory bowel disease who are in 'clinical' remission
Kings College Hospital NHS Foundation Trust (UK)0 个研究点目标入组 160 人开始时间: 2010年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients aged 18 - 65 years, either sex
- •2. Minimum 6 months history of inflammatory bowel disease
- •3. Confirmed both endoscopically and histologically
- •4. Three months of 'stable clinical remission' - including no change in treatment during the preceding 3 months
排除标准
- •1. Aged less than 16 years and greater than 65 years
- •2. Severe disease or current disease flare
- •3. Current use of biological or immunosupressive treatments (including infliximab, adalimumab, methotrexate, azathioprine, 6-mercaptopurine, cyclosporin). Patients who are taking azathioprine or 6-mercaptopurine who have been stable on treatment for a minimum of 12 weeks without major side effects or adverse events will not be excluded.
- •4. Previous complicated bowel resections or multiple bowel resections
- •5. Pregnancy or actively seeking pregnancy
- •6. History of intolerance or allergy to probiotics
- •7. Significant comorbid conditions (to be judged by the research doctor at assessment)
- •8. Significant psychiatric comorbidity (to be judged by the research doctor at assessment)
- •9. Current drug or alcohol dependence syndrome
研究者
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