A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- bacteria translocation in MLN, mesenteric fat and peripheral blood
研究概览
简要总结
The purpose of this study is to evaluate the effect of soluble dietary fiber on bacterial translocation and mucosal immunology in patients with Crohn's disease.
详细描述
Bacterial translocation (BT) is a proposed mechanism of CD. Microorganisms can be cultured from 18-48% of draining mesenteric lymph nodes from CD patients. A breakdown in barrier function in "late stage" CD has been observed in patients requiring surgery. In addition, it was found that BT influences the response to biological therapy and clinical relapse in CD. Therefore, reducing BT may be of therapeutic importance in treatment for CD.
The role of soluble dietary fiber in Crohn's disease (CD) is still inconclusive. Population based studies have shown that long-term intake of dietary fiber is associated with lower risk of CD. However, meta-analysis did not show benefit in inducing or maintaining remission. In addition, the possible mechanism of dietary fiber on CD is still unclear.
The rationale relates to the beneficial effects of fiber may be due to the production of the fiber metabolites short-chain fatty acids (SCFAs), particularly butyrate. Dietary substrates may modify the commensal microbiota or their metabolites or enhance epithelial barrier function. Recently, it was found that dietary fiber metabolites SCFA is regulatory of mucosal regulatory T cells. The current study is to examine the impact of dietary fiber on bacterial translocation,intestinal luminal microbiology, and mucosal immunology in CD patients.
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
- None
入排标准
- 年龄范围
- 17 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >=17 years with diagnosis of CD for at least 3 months defined by histology or radiology
- •ileocolonic non-penetrating disease
- •Moderate active CD with CDAI 250-450
- •CRP level over normal range
- •Stable CD therapy with a total steroid dose not exceeding 10mg prednisolone or equivalent for 4 weeks
排除标准
- •Infection with enteric pathogen
- •Usage of probiotics, antibiotics, or prebiotics within the last month
- •Change in dose of oral steroids or 5-ASA within the last 4 weeks or AZA or MTX in the last 3 months
- •Dose of steroids exceeds 10 mg prednisolone per day or equivalent
- •Infusion of IFX or any alternative biological therapy within the last 3 months
- •Use of rectal 5-ASA or steroids within the last 2 weeks.
- •Imminent need for surgery or presence of severe disease (CDAI >450)
- •Pregnancy or lactation
- •Short bowel syndrome or subtotal/total colectomy
- •Pure anal disease and previous proctocolectomy
- •Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator
- •History of cancer with a disease-free state of less than two years
- •Patients with penetrating disease or small bowel lesion only.
研究组 & 干预措施
control
Patients allocated to control group will receive standard enteral nutrition formula(Fresubin) for 4 weeks
干预措施: pectin (Drug)
pectin
Patients allocated to experiment group will receive standard enteral nutrition formula(Fresubin) supplemented with 15g pectin each day for 4 weeks.
干预措施: pectin (Drug)
结局指标
主要结局
bacteria translocation in MLN, mesenteric fat and peripheral blood
时间窗: 4 weeks after treatment
Bacterial translocation to mesenteric lymph nodes (MLN),mesenteric fat and peripheral blood during laparotomy before surgical mobilization, as determined by DGGE.
次要结局
- change of fecal bacteriology(baseline, week 4)
- change of fecal SCFA(baseline, week 4)
- adverse events(up to 4 weeks after treatment)
- clinical response(up to 4 weeks after treatment)
- change of mucosal Treg numbers(baseline, week 4)
研究者
Jianfeng Gong
Associate professor
Jinling Hospital, China