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临床试验/ISRCTN31320381
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

发起方
Kings College Hospital NHS Foundation Trust (UK)

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