Characteristic of Intestinal Flora in Male Elderly With Small Intestinal Bacterial Overgrowth

Overview

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

Full Title of Study: “Study on Clinical Features, Intestinal Flora and Standardized Treatment in Male Elderly With Small Intestinal Bacterial Overgrowth”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 10, 2019

Detailed Description

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.

Interventions

  • Other: SIBO
    • SIBO: Small intestinal bacterial overgrowth, refers to a bacterial overgrowth due to organic or functional stasis in small intestine, leading to the change in number or types of bacteria in small intestine.

Arms, Groups and Cohorts

  • male elderly with SIBO
    • male elderly who was diagnosed as SIBO via ‘lactulose breath test’ (LBT). At the same time, they meet the following criteria: no use of antibiotics in the past 1 month. no use of prokinetic drugs and probiotics in the past 1 week. without these diseases: active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease.
  • male elderly without SIBO
    • male elderly without SIBO after ‘lactulose breath test’. At the same time, they meet the following criteria: no use of antibiotics in the past 1 month. no use of prokinetic drugs and probiotics in the past 1 week. without these diseases: active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease.

Clinical Trial Outcome Measures

Primary Measures

  • amplicon sequencing of intestinal microflora
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

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

Gender Eligibility: Male

male

Minimum Age: 65 Years

Maximum Age: 98 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ru Zhang MD, doctor of medcine – Chinese PLA General Hospital
  • Overall Official(s)
    • Jun Wan, Study Director, director

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