Colorectal NeoplasiaNCT02063919
Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome
An observational study of Colorectal Neoplasia and Colorectal Inflammation, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasia, Colorectal Inflammation, Hyperplasia
- What is being tested?
- the mucosal microbiome in the biopsy specimen was analysed
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.
Who may be able to join
- 18 years old ≤ age < 80 years old
- Scheduled for colonoscopy in Qilu Hospital
Who cannot join
- antibiotic usage within 2 months
- probiotic or prebiotic usage within 2 months
- ascites
- jaundice
- liver cirrhosis
- impaired renal function
Show all 12Show fewer
- coagulopathy
- fever
- pregnancy
- breastfeeding
- inability to provide informed consent
- known allergy to fluorescein sodium
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.
Read the detailed description
The gut microbiome plays a pivotal role in the intestinal pathophysiology. The mucosal microbiome is in the front face of microbiome-host cross-talk. Confocal laser endomicroscopy (CLE) can provide realtime mucosal images during ongoing endoscopy. We hypothesized that the mucosal pattern, here evaluated by endomicroscopy, may constitute specific microbiome niches and participate the evolvement of the mucosal microbiome.
- Being tested
- the mucosal microbiome in the biopsy specimen was analysed
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the mucosal microbiome in the biopsy specimen was analysedOther
| Study group | Role | What they receive |
|---|---|---|
| endomicroscopy | Not described Receives: Other: the mucosal microbiome in the biopsy specimen was analysed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The operational taxonomy unit in the colorectal 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 posted17 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasiaStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD., MD., Principal investigator, Department of gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063919
- Sponsor's protocol ID
- 2014SDU-QILU-G01
- Status last verified
- Jun 2015
- First submitted
- 29 Jan 2014
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome
- ClinicalTrials.gov ID
- NCT02063919
- Acronym / sponsor ID
- 2014SDU-QILU-G01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- 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.
The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.
Detailed description
The gut microbiome plays a pivotal role in the intestinal pathophysiology. The mucosal microbiome is in the front face of microbiome-host cross-talk. Confocal laser endomicroscopy (CLE) can provide realtime mucosal images during ongoing endoscopy. We hypothesized that the mucosal pattern, here evaluated by endomicroscopy, may constitute specific microbiome niches and participate the evolvement of the mucosal microbiome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endomicroscopy | – | Other: the mucosal microbiome in the biopsy specimen was analysed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.
Key inclusion criteria (2 listed)
- 18 years old ≤ age < 80 years old
- Scheduled for colonoscopy in Qilu Hospital
Key exclusion criteria (12 listed)
- antibiotic usage within 2 months
- probiotic or prebiotic usage within 2 months
- ascites
- jaundice
- liver cirrhosis
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 |
|---|---|---|
| the mucosal microbiome in the biopsy specimen was analysed | Other | endomicroscopy |
Primary outcome
The operational taxonomy unit in the colorectal mucosal microbiome.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 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.
Yanqing Li, PhD., MD. principal investigator
Department of gastroenterology, Qilu Hospital, 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 Colorectal Neoplasia and Colorectal Inflammation, 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 12 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: finished, as of the sponsor's last update on 30 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The operational taxonomy unit in the colorectal 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 30 Jun 2015.