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

NCT03659175 | Unknown

• 1 other identifier: RZhang
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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: 1. no use of antibiotics in the past 1 month. 2. no use of prokinetic drugs and probiotics in the past 1 week. 3. 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

male elderly without SIBO

male elderly without SIBO after 'lactulose breath test'. At the same time, they meet the following criteria: 1. no use of antibiotics in the past 1 month. 2. no use of prokinetic drugs and probiotics in the past 1 week. 3. without these diseases: active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease.

Interventions

SIBO OTHER

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 with SIBO

Eligibility Criteria

• Age: 65 Years - 98 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA general hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

feces and intestinal biopsy

Study Officials

• Jun Wan

  Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor of medcine

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: September 6, 2018
• Study Start: October 15, 2018
• Primary Completion: December 10, 2019
• Study Completion: May 10, 2020
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)