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临床试验/NCT03420599
NCT03420599Unknown不适用

Altered Microbiota is Related Increased Infection Rates After Traumatic Splenectomy

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Transcriptional changes in gut microbiota

研究概览

简要总结

Studies has shown an increasingly infection rate after splenectomy, and there is a potential correlation between microbiota and immune system. investigators suppose that increasingly infection can be associated with the alteration composition of the gut microbiota after splenectomy. It's investigators' aim to discover if any difference of gut microbiota is exist in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim toreduce and mitigation infection rate through controlling gut microbiota.

详细描述

The spleen is crucial in regulating immune homoeostasis through its ability to link innate and adaptive immunity and to protect against infections. Asplenia refers to the absence of the spleen, a disorder that is rarely congenital and is more frequently as a result of surgery. Splenic hypofunction, as a result of asplenia can lead a series of changes in body systems. Recent study has show an increasingly infection rate after splenectomy including abdominal infection, pulmonary infection and cranial cavity infection.

The gastrointestinal tract plays host to a diverse and metabolically complex community of microorganisms. Recent literature suggests that organisms in the gastrointestinal tract, referred to collectively as gut microbiota, play an indispensable role in the maintenance of host's homeostasis. Study has proved a potential correlation between microbiota and immune system. Lymphocyte, in either peripheral circulation or mesenteric lymph node, altered can lead to an composition change in microbiota.

Investigators suppose that this phenomenon can be associated with the alteration of the resident commensal microenvironment after splenectomy compared to commensal communities. It's investigators' aim to discover if any difference of gut microbiota is exist in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim toreduce and mitigation infection rate through controlling gut microbiota.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All the patients underwent an total splenectomy in the First Affiliated Hospital of Harbin Medical University from January 1st, 2015 to May 1st,
  • Each participant provided a fresh stool sample in hospital when following-up.

排除标准

  • Use antibiotics and probiotics 3 mouth before samples collection.
  • Other severe abdomen injury
  • Underwent abdomen organ resection surgery
  • Other digestive system disease

结局指标

主要结局

Transcriptional changes in gut microbiota

时间窗: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

16S rRNA gene sequencing will be performed with stander procedure

Transcriptional changes in plasma LPS levels

时间窗: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

Plasma LPS level will be measured by ELISA

次要结局

  • Fecal SIgA(Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery)
  • Fecal calprotectin(Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery)
  • Plasma DAO(Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery)
  • Plasma D-Lac(Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery)

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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