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临床试验/NCT03659175
NCT03659175Unknown不适用

Study on Clinical Features, Intestinal Flora and Standardized Treatment in Male Elderly With Small Intestinal Bacterial Overgrowth

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
amplicon sequencing of intestinal microflora

研究概览

简要总结

We will focus on the intestinal flora structure, risk factors and clinical features of male elderly with SIBO in our study.

详细描述

Our previous study had found that the prevalence rate of small intestinal bacterial overgrowth(SIBO) in male elderly was high up to 63.1%. In the recent years, SIBO has been found be associated not only with abdominal symptoms such as abdominal distention, pain and so on, but also with various diseases such as diabetes, Alzheimer's disease, joint pain, chronic prostatitis, fatty liver, liver cirrhosis etc. SIBO has significant impact on the health of elderly. Methane and hydrogen lactulose breath test(LBT) is effective and noninvasive for the diagnosis of SIBO. High throughput sequencing is a leading technique for the study of intestinal microflora.

Although more and more studies have focused their concern on the intestinal flora now, few SIBO-related studies are available in elderly patients. But we have found SIBO was very popular in the elderly. The conflict between high prevalence rate of SIBO in elderly and very few relevant studies is barrier to study of pathophysiology, early diagnosis and treatment of SIBO in elderly adults.

So in our study, we will apply LBT and high throughput sequencing technique to study the intestinal flora structure, risk factors and clinical features of male elderly patients with SIBO. And further, we will try to develop standard treatment for elderly patients with SIBO.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 98 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • no use of antibiotics in the past 1 month, no use of prokinetic drugs and probiotics in the past 1 week

排除标准

  • active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease

结局指标

主要结局

amplicon sequencing of intestinal microflora

时间窗: 1 year

We will collect specimen(include feces and intestinal biopsy), then amplicon sequencing of intestinal microflora in specimen. And study the difference in intestinal microflora structure bwteen male elderly with and without SIBO.

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ru Zhang MD

doctor of medcine

Chinese PLA General Hospital

研究点 (1)

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