Mucosal MicrobiomeNCT02428426
Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.
An observational study of Mucosal Microbiome and Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosal Microbiome, Gastric Intestinal Metaplasia, Duodenum
- What is being tested?
- endomicroscopy, targeted biopsy and 16s rRNA gene sequencing
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jul 2015
- 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
- Healthy volunteers accepted
- 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,gastric inhibitor usage within 1 month 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, PhD. MD., 86-531-82169236 ext. 82169508, qiluliyanqing@gmail.com
Yanqing Li, PhD. MD.
About this study
To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue.
- Conditions
- Mucosal Microbiome, Gastric Intestinal Metaplasia, Duodenum
- Being tested
- endomicroscopy, targeted biopsy and 16s rRNA gene sequencing
- Keywords
- Mucosal Microbiome, gastric intestinal metaplasia, duodenum
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 |
|---|---|---|
| gastric intestinal metaplasia | patients were diagnosed gastric intestinal metaplasia Receives: Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing | |
| gastritis | patients were diagnosed non atrophic gastritis 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 Intestinal Metaplasia and and Duodenal mucosal microbiome
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 posted28 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- li yanqing, PhD,MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428426
- Sponsor's protocol ID
- 2015SDU-QILU-G04
- Status last verified
- Apr 2015
- First submitted
- 23 Apr 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.
- ClinicalTrials.gov ID
- NCT02428426
- Acronym / sponsor ID
- 2015SDU-QILU-G04
- Conditions
- Mucosal Microbiome, Gastric Intestinal Metaplasia, Duodenum
- Keywords
- Mucosal Microbiome, gastric intestinal metaplasia, duodenum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 28 Apr 2015 (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.
To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric intestinal metaplasia | – | Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencingpatients were diagnosed gastric intestinal metaplasia |
| gastritis | – | Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencingpatients were diagnosed non atrophic gastritis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
Key inclusion criteria (1 listed)
- Patients scheduled for gastroendoscopy examination Aged between 18 and 80 years old
Key exclusion criteria (1 listed)
- Antibiotic, probiotic or prebiotic usage within 2months,gastric inhibitor usage within 1 month 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
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 | gastric intestinal metaplasia, gastritis |
Primary outcome
The operational taxonomy units in gastric Intestinal Metaplasia and and Duodenal mucosal microbiome
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 28 Apr 2015.
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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.
li yanqing, PhD,MD principal investigator
Qilu Hospital of Shandong University
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 Gastric Intestinal Metaplasia, 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 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 28 Apr 2015. 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?
Contact li yanqing, PhD,MD (86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The operational taxonomy units in gastric Intestinal Metaplasia and and Duodenal 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 28 Apr 2015.