ISRCTN19271131已完成不适用
Gut microbiota in patients with Crohn's disease and their relatives: a case-control study of the gut microbiota and related immunological and biochemical markers of gut inflammation in patients with quiescent Chrohn's disease and the effect of a prebiotic diet
Barts and The London NHS Trust (UK)0 个研究点目标入组 72 人开始时间: 2010年6月18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
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Aged 16 years or older, either sex
- •2. Diagnosis of Crohn's disease for at least 3 months defined by histology or radiology
- •3. Quiescent (inactive) disease as defined by a Crohn's Disease Activity Index (CDAI) below 150
- •4. Normal C-reactive protein (CRP) as defined by local laboratory
- •5. On stable Crohn's disease therapy with a total steroid dose not exceeding 10 mg prednisolone or equivalent
- •6. Relatives of patients:
- •6.1. Will be aged between 16 and 35 years
- •6.2. Will be a first degree relative of a patient as described above. Relatives older than 35 will not be recruited to maximise the chance of including some individuals who will develop Crohn's disease in the future.
- •7. Healthy controls will comprise age-matched patients with functional constipation or those undergoing polyp surveillance who are scheduled to undergo flexible sigmoidoscopy. A second group of controls who will not undergo sigmoidoscopy will comprise healthy volunteers.
- •Concomitant medication:
- •Patients currently taking maintenance oral 5 aminosalicylic acid (5ASA) therapy must have been on a stable dose for 4 weeks prior to study entry, and will be maintained at the same dose for the duration of the study. No rectally administered medications (steroid or 5ASA) are allowed for the two weeks preceding entry to the study. Patients on a stable dose of oral (not exceeding 10 mg) prednisolone or equivalent for 4 weeks prior to baseline are permitted to enter the study. Patients taking azathioprine or 6 mercaptopurine must have commenced the drug at least 16 weeks prior to entry to the study and been maintained on a stable dose for at least 4 weeks prior to entry. No antibiotics, probiotics or prebiotics will be used during the study or for the preceding month. Non-steroidal anti-inflammatory drugs (NSAIDs) will not be permitted for 1 week before entry to the study. The requirement for a normal CRP is to ensure inactive disease.
- •For participants in study two, no changes in medication will be permitted during the study period. Participants requiring changes to their drug regime will be withdrawn from the study and continue with their usual medical care.
排除标准
- •The principal exclusion criteria are standard for this type of trial in Crohn's disease.
- •All participants:
- •1. Current infection with an enteric pathogen
- •2. Use of antibiotics within the last month
- •3. Consumption of any probiotic or prebiotic within the last month
- •4. Change in dose of oral steroids within the last 4 weeks
- •5. Dose of steroids exceeding 10 mg prednisolone per day or equivalent
- •6. Change in dose of oral 5 ASA products within the last 4 weeks
- •7. Commencement of azathioprine or methotrexate within the last 4 months or change in dose of these drugs within the last 4 weeks
- •8. Infusion of infliximab within the last 3 months
- •9. Use of any alternative biological therapy within the last 3 months
- •10. Use of rectal 5 ASA or steroids within the last 2 weeks
- •11. Imminent need for surgery
- •12. Participant requiring hospitalisation
- •13. Pregnancy or lactation
- •14. Short bowel syndrome and previous proctocolectomy or purely anal Crohn's disease
- •15. Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator
- •16. A history of cancer with a disease-free state of less than 2 years
- •17. Evidence of active Crohn's disease as defined by a CDAI of greater than 150
- •18. Previously been diagnosed with inflammatory bowel disease
- •19. Previously been diagnosed with inflammatory bowel disease
- •20. First or second degree relative with inflammatory bowel disease
研究者
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