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

NCT ID: NCT03659175

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2020-05-10

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

SIBO

Intervention Type: 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 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.

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 98 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ru Zhang MD

doctor of medcine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Wan

Role: STUDY_DIRECTOR

Director

Locations

Chinese PLA general hospital

Beijing, , China

Countries

China

Other Identifiers

RZhang

Identifier Type: -

Identifier Source: org_study_id