NCT02063919

Brief Summary

The purpose of this study is to determine whether an association between endomicroscopic pattern and colorectal mucosal microbiome exists.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 30, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

January 29, 2014

Last Update Submit

June 27, 2015

Conditions

Colorectal NeoplasiaColorectal InflammationHyperplasiaMucosal Microbiome

Outcome Measures

Primary Outcomes (1)

  • The operational taxonomy unit in the colorectal mucosal microbiome.

    6 months

Study Arms (1)

endomicroscopy

Other: the mucosal microbiome in the biopsy specimen was analysed

Interventions

the mucosal microbiome in the biopsy specimen was analysedOTHER
endomicroscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.

You may qualify if:

  • years old ≤ age \< 80 years old
  • Scheduled for colonoscopy in Qilu Hospital

You may not qualify if:

  • antibiotic usage within 2 months
  • probiotic or prebiotic usage within 2 months
  • ascites
  • jaundice
  • liver cirrhosis
  • impaired renal function
  • coagulopathy
  • fever
  • pregnancy
  • breastfeeding
  • inability to provide informed consent
  • known allergy to fluorescein sodium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The mucosal metagenome was obtained from biopsy specimen.

MeSH Terms

Conditions

Hyperplasia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yanqing Li, PhD., MD.

    Department of gastroenterology, Qilu Hospital, Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 17, 2014

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

June 30, 2015

Record last verified: 2015-06

Locations

CN(1)