A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change of intestinal flora of stool
研究概览
简要总结
The pathogenesis of Crohn Disease (CD) is unknown, but there is evidence show that the inadequate immune response or overreaction of the immune system against food antigens or components of the commensal flora involve it. Corticosteroid therapy is effective for adult patients with CD, but it has side effects and can't promote mucosal healing. In recent years, Enteral nutrition (EN) is becoming primary therapy in induction and maintenance remission of CD, especially in children. But the mechanism of EN in induction and maintenance remission of CD is still unclear, and parts of patient have good clinical response to EN therapy while other don't. So we design the study to explore whether EN treats CD by effecting intestinal flora and whether the intestinal flora of patient with CD relates with clinical response.
详细描述
The pathogenesis of CD is unknown, but there is evidence show that the inadequate immune response or overreaction of the immune system against food antigens or components of the commensal flora involve it. Corticosteroid therapy is effective for adult patients with CD, but it has side effects and can't promote mucosal healing. In recent years, EN is becoming primary therapy in induction and maintenance remission of CD, especially in children. But the mechanism of EN in induction and maintenance remission of CD is still unclear, and parts of patient have good clinical response to EN therapy while other don't. So we design the study to explore whether EN treats CD by effecting intestinal flora and whether the intestinal flora of patient with CD relates with clinical response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients should be in the age range of 18 - 75 years;
- •Patients should have clinical, imaging, endoscopic and histological diagnosis of CD based on WHO criteria
- •Patients should have a CDAI score of more than 150 and have a CRP level of more than 10mg/L at enrollment;
- •Patients will not be excluded if they have received 5-ASA(Aminosalicylic acid) or immunomodulator for >8 weeks and the dose is stable
- •Informed consent
排除标准
- •Patients who can't tolerate enteral nutrition because of complications, such as complete intestinal obstruction, gastrointestinal perforation or bleeding etc.
- •Patients who receive corticosteroids or enteral nutrition or prebiotics /probiotics/synbiotics/antibiotic treatment in the previous 4 weeks.
- •Patients who accompanied extra-intestinal manifestations, serve complications, and active perianal disease and need other drug therapies.
- •Patients who had ostomy or colectomy or subtotal colectomy
- •Patients with end-stage disease or is expected likely to die during the study
- •Patients are participating in other clinical trials or participated within 6 months prior to this study
研究组 & 干预措施
enteral nutrition
The patients receive treatment of enteral nutrition only.
干预措施: enteral nutrition (Dietary Supplement)
Corticosteroid
The patients receive treatment of corticosteroid only.
干预措施: corticosteroid (Drug)
结局指标
主要结局
change of intestinal flora of stool
时间窗: 6 weeks
Change from baseline in diversity and composition of intestinal flora of stool every week and time point of clinical remission after intervention
次要结局
- CDAI(Crohn's disease activity index)(6 weeks)
- Fecal Calcium Protein(6 weeks)
- biochemical indexes(6 weeks)
研究者
Zhu Weiming
professor
Jinling Hospital, China