Characteristic of Intestinal Flora in Male Elderly With Small Intestinal Bacterial Overgrowth (IFOSIBO)

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

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

Study Overview

• Status: Unknown
• Conditions: Elderly; Small Intestinal Bacterial Overgrowth; Male; 16s rRNA
• Intervention / Treatment: Other: SIBO

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 98 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

male elderly outpatients at Department of Gastroenterology, Nanlou Division, Chinese PLA General Hospita, Beijing, China

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Director: Jun Wan, Director

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2018
• Primary Completion (ANTICIPATED): December 10, 2019
• Study Completion (ANTICIPATED): May 10, 2020

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: September 2, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 2, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RZhang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the data of these male elederly enrolled in the study are secret on account of their status

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No