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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03659175
Other study ID # RZhang
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 15, 2018
Est. completion date May 10, 2020

Study information

Verified date September 2018
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date May 10, 2020
Est. primary completion date December 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years to 98 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Chinese PLA general hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary amplicon sequencing of intestinal microflora 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. 1 year
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