Small Intestinal Bacterial OvergrowthIFOSIBONCT03659175
Characteristic of Intestinal Flora in Male Elderly With Small Intestinal Bacterial Overgrowth
An observational study of Small Intestinal Bacterial Overgrowth and Elderly, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
We will focus on the intestinal flora structure, risk factors and clinical features of male elderly with SIBO in our study. Read more about this study
- Who is it for?
- Ages 65 to 98 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth, Elderly, Male
- What is being tested?
- SIBO
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2018to 10 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 98 years
- Men only
- Healthy volunteers accepted
- Older adult
Study population: male elderly outpatients at Department of Gastroenterology, Nanlou Division, Chinese PLA General Hospita, Beijing, China
Who may be able to join
- no use of antibiotics in the past 1 month, no use of prokinetic drugs and probiotics in the past 1 week
Who cannot join
- active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- SIBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBOOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start15 Oct 2018 (estimated)
- Primary completion10 Dec 2019 (estimated)
- Study completion10 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru Zhang MD, Chinese PLA General Hospital
- Investigators
- Jun Wan, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659175
- Sponsor's protocol ID
- RZhang
- Acronym
- IFOSIBO
- Status last verified
- Sep 2018
- First submitted
- 10 Jan 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data of these male elederly enrolled in the study are secret on account of their status
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Clinical Features, Intestinal Flora and Standardized Treatment in Male Elderly With Small Intestinal Bacterial Overgrowth
- ClinicalTrials.gov ID
- NCT03659175
- Acronym / sponsor ID
- IFOSIBO / RZhang
- Conditions
- Small Intestinal Bacterial Overgrowth, Elderly, Male, 16s rRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 10 Dec 2019 (estimated)
- Study completion
- 10 May 2020 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male elderly with SIBO | – | Other: SIBOmale 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. |
| 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. |
Who may qualify
- Ages
- 65 to 98 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- male elderly outpatients at Department of Gastroenterology, Nanlou Division, Chinese PLA General Hospita, Beijing, China
Key inclusion criteria (1 listed)
- no use of antibiotics in the past 1 month, no use of prokinetic drugs and probiotics in the past 1 week
Key exclusion criteria (1 listed)
- active inflammation, cardiac insufficiency, respiratory insufficiency, hepatic insufficiency, renal insufficiency, cirrhosis, thyroid diseases, Crohn disease, ulcerative colitis, hepatobiliary and pancreatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIBOSIBO: 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. | Other | male elderly with SIBO |
Primary outcome
amplicon sequencing of intestinal microflora
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No. the data of these male elederly enrolled in the study are secret on account of their status
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Wan study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Intestinal Bacterial Overgrowth and Elderly, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amplicon sequencing of intestinal microflora (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.