ISRCTN50422530已完成不适用
A randomised, double-blind comparison of the microbiological, immunological and clinical effects of a high fructooligosaccharide diet compared with standard diet in patients with moderately active Crohn's disease
Barts and the London NHS Trust0 个研究点目标入组 110 人开始时间: 2006年6月16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
- 110
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. The study group will include patients aged 18 years or older with a diagnosis of Crohn?s disease for at least three months defined by histology or radiology
- •2. Patients must have moderately active disease as defined by a Crohns disease activity index (CDAI) between 250 and 450 at the baseline visit
- •3. Only patients with a C-reactive protein (CRP) elevated to above the upper limit of normal of the local laboratory will be included
- •4. Patients must be on stable Crohn?s disease therapy with a total steroid dose not exceeding 10 mg prednisolone or equivalent
- •5. Patients currently taking maintenance oral 5-aminosalicylic acid therapy must have been on a stable dose for four weeks prior to study entry, and will be maintained at the same dose for the six-week duration of the study
- •6. No rectally administered medications (steroid or 5-aminosalicylic acid [5ASA]) are allowed for the two weeks preceding baseline and throughout the study
- •7. Patients on a stable dose of oral steroids (not exceeding 10 mg prednisolone or equivalent) for four weeks prior to baseline are permitted to enter the study, and will remain on that dose throughout the study
- •8. Patients taking azathioprine or 6-mercaptopurine must have been maintained on a stable dose for at least 16 weeks prior to entry and will continue at that dose throughout the study
- •9. No antibiotics, probiotics or prebiotics (other than the study prebiotic) will be used during the study or for the preceding month
- •10. Food frequency questionnaires will be used to assess the consumption of foods that naturally contain prebiotics, although levels within a normal western diet are usually insufficient to affect the composition of the intestinal microbiota
- •11. Non-steroidal anti-inflammatory drugs (NSAIDs) will not be permitted for one week before and throughout the six-week study period
排除标准
- •1. Current infection with an enteric pathogen
- •2. Use of antibiotics within the last month
- •3. Consumption of any probiotic within the last month
- •4. Change in dose of oral steroids within the last four weeks
- •5. Dose of steroids exceeds 10 mg prednisolone per day or equivalent
- •6. Change in dose of oral 5-ASA products within the last four weeks
- •7. Change in dose of azathioprine or methotrexate within the last three months
- •8. Infusion of infliximab within the last three months
- •9. Use of any alternative biological therapy within the last three months
- •10. Use of rectal 5-ASA or steroids within the last two weeks
- •11. Imminent need for surgery or presence of severe disease (CDAI >450)
- •12. Patient requiring hospitalization
- •13. Pregnancy or lactation
- •14. Short bowel syndrome
- •15. Pure anal disease and previous proctocolectomy
- •16. Patients will also be excluded if they have significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator
- •17. History of cancer with a disease-free state of less than two years
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