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Clinical Trials/NCT03659175
NCT03659175
Unknown
Not Applicable

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

Chinese PLA General Hospital1 site in 1 country40 target enrollmentStarted: October 15, 2018Last updated:

Overview

Phase
Not Applicable
Sponsor
Chinese PLA General Hospital
Enrollment
40
Locations
1
Primary Endpoint
amplicon sequencing of intestinal microflora

Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to 98 Years (Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chinese PLA General Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ru Zhang MD

doctor of medcine

Chinese PLA General Hospital

Study Sites (1)

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