Mucosal MicrobiomeNCT02063932
Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome
An observational study of Mucosal Microbiome and H.Pylori, run by Shandong University at 1 site in China.
Trial summary
There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mucosal Microbiome, H.Pylori, Intestinal Metaplasia
- What is being tested?
- endomicroscopy, targeted biopsy and 16s rRNA gene sequencing
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jun 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
Who may be able to join
- Patients scheduled for gastroendoscopy examination
- Aged between 18 and 80 years old
Who cannot join
- Antibiotic, probiotic or prebiotic usage within 2months
- Esophageal, gastric or duodenal cancer or other malignancy
- History of upper GI tract surgery
- Coagulopathy or bleeding disorders
- Allergy to fluorescein sodium
- Pregnant or breast-feeding (for females)
- Impaired renal function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD. PhD., 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
Yanqing Li, MD. PhD.
About this study
There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.
Read the detailed description
The gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the H.pylori infection. We hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.
- Conditions
- Mucosal Microbiome, H.Pylori, Intestinal Metaplasia, Gastric Neoplasia
- Being tested
- endomicroscopy, targeted biopsy and 16s rRNA gene sequencing
- Keywords
- mucosal microbiome, H.pylori, intestinal metaplasia, gastric neoplasia, endomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endomicroscopy, targeted biopsy and 16s rRNA gene sequencingOther
| Study group | Role | What they receive |
|---|---|---|
| endomicroscopy | Not described Receives: Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The operational taxonomy units in gastric mucosal microbiome
Measured: 6 months
Secondary outcomes (1)
The diagnostic accuracy of endomicroscopy compared to pathology.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal MicrobiomeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063932
- Sponsor's protocol ID
- 2014SDU-QILU-G02
- Status last verified
- Jan 2014
- First submitted
- 29 Jan 2014
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome
- ClinicalTrials.gov ID
- NCT02063932
- Acronym / sponsor ID
- 2014SDU-QILU-G02
- Conditions
- Mucosal Microbiome, H.Pylori, Intestinal Metaplasia, Gastric Neoplasia
- Keywords
- mucosal microbiome, H.pylori, intestinal metaplasia, gastric neoplasia, endomicroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- 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.
There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.
Detailed description
The gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the H.pylori infection. We hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endomicroscopy | – | Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
Key inclusion criteria (2 listed)
- Patients scheduled for gastroendoscopy examination
- Aged between 18 and 80 years old
Key exclusion criteria (7 listed)
- Antibiotic, probiotic or prebiotic usage within 2months
- Esophageal, gastric or duodenal cancer or other malignancy
- History of upper GI tract surgery
- Coagulopathy or bleeding disorders
- Allergy to fluorescein sodium
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 |
|---|---|---|
| endomicroscopy, targeted biopsy and 16s rRNA gene sequencing | Other | endomicroscopy |
Primary outcome
The operational taxonomy units in gastric mucosal microbiome
Time frame: 6 months
1 secondary outcome
The diagnostic accuracy of endomicroscopy compared to pathology.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
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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.
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, China
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 Mucosal Microbiome and H.Pylori, run by Shandong University 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 2 inclusion and 7 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 17 Feb 2014. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The operational taxonomy units in gastric mucosal microbiome (time frame: 6 months). 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 17 Feb 2014.