Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Changes in composition of the microbiome between treatment groups
研究概览
简要总结
The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.
详细描述
These are two are different ways to re-connect the intestines after a portion of it is removed during surgery. Patients will be randomly assigned to either be re-connected with a procedure called the Kono-S anastomosis or with a side-to-side anastomosis during their surgery. This study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. Then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. This will be used to see how the microbiome and immune system in that area changed since the surgery. Genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Crohn's ileitis/ileocolitis requiring surgical resection OR patients previously enrolled in the "Kono-S anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn's Disease (WC IRB #1303013645)" trial.
- •Patients age 18 years and older.
- •All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3) according to the Vienna classification.
- •Patients will be included regardless of preoperative medications (untreated, steroids, biologics)
排除标准
- •Patients under 18 years of age.
- •Pregnant patients.
- •Patient does not speak English
- •Patients that may need a different surgical procedure as per the surgeon at the time of intraoperative evaluation
结局指标
主要结局
Changes in composition of the microbiome between treatment groups
时间窗: At the time of the surgery
Microbiome composition will be measured via an analysis of of 16S rRNA sequencing from tissue samples.
Changes in the immune cell environment between treatment groups
时间窗: 3-6 month, 12-18 month and 60 month post-surgery endoscopy.
Immune cell environment in the tissue will be measured by gene expression levels in the tissue sample via bulk RNA sequencing.
次要结局
未报告次要终点