ACTRN12616000251426尚未招募不适用
Randomized Ileal Crohn’s disease study of exclusive Enteral Nutrition (RICE study)
Concord Hospital, Department of Gastroenterology0 个研究点目标入组 90 人开始时间: 2016年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Participant must meet all of the inclusion criteria below at time of enrolment to be eligible to participate in phase 1 of the study
- •1.Crohn’s disease involving the terminal ileum, established diagnosis >6 months
- •2.Aged 18 – 70 inclusive
- •3.Ileal complicated Crohn’s disease requiring laparoscopic / open ileal (or small bowel segmental) resection, OR severe ileal Crohn’s disease
- •Participant must meet all of the inclusion criteria below at time of surgery to be eligible to participate in phase 2 of the study:
- •1.Crohn’s disease involving the terminal ileum, established diagnosis >6 months
- •2.Aged 18 – 70 inclusive
- •3.Ileal complicated Crohn’s disease undergoing laparoscopic / open ileal (or small bowel segmental) resection
- •4.Terminal ileum can be reached by colonoscopy.
排除标准
- •Participant must not meet any of the exclusion criteria below at time of enrolment to be eligible to participate in either phase 1 or phase 2 of the study
- •1.Unable to consent, comply or complete the study and associated procedures (such as understanding of questionnaires)
- •2.Requirement for emergency small bowel resection eg. those with uncontrolled sepsis or peritonitis or complete bowel obstruction
- •3.Short bowel syndrome or any other significant gastrointestinal disease (eg irritable bowel syndrome, active neoplasm, diverticulitis etc)
- •4.Colectomy, stoma formation ie. non-primary anastomosis, or strictureplasty without small bowel resection
- •5.Resection for malignancy or known colorectal dysplasia (apart from polyps that have been completely removed)
- •6.Pregnancy, lactation or unwillingness to practice an effective method of contraception during the study period
- •7.Ulcerative colitis or IBD unclassified
- •8.Comorbidity or psychiatric disorder sufficiently severe to jeopardize participation
研究者
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