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

Elderly Clinical Trial

— IFOSIBO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03659175
• Other study ID #: RZhang
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• 16s rRNA
• Elderly
• Male
• Small Intestinal Bacterial Overgrowth

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