- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065324
Balloon-assisted Enteroscopy and Bacteria
February 8, 2010 updated by: National Taiwan University Hospital
Intestinal Barrier Permeability Defects, Recovery, and Risk of Bacterial Translocation Induced After Deep Intestinal Manipulation by Balloon-assisted Enteroscopy: From Basic to Clinical Research
- Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases.
- Deep enteroscopy made possible by balloon expansion and manipulation of small intestines.
- However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied.
- We will also examine relevant patient factors.
Study Overview
Detailed Description
The newly developed balloon-assisted enteroscopy systems allow insertion of the enteroscopy deeply into the small intestines by fixation of the soft, redundant small intestines with an inflatable balloon over the tip of the overtube.
However, the inflation of balloon might stimulate the intestinal mucosa, and the deep manipulation of intestinal segments might also compromise the intestinal barrier function.
According to our preliminary experience of balloon-assisted enteroscopy (which is among the first groups in Taiwan), we experienced a significant case of suspected post-procedural bactermia patient.
Besides, there is also a published case report from the UK reporting Streptococcus milleri bacteremia which is suspected as bacterial translocation after balloon-assisted enteroscopy.
However, currently there is no original study focusing on the intestinal barrier / permeability defects or bacterial translocation.
This is a timely and novel research topic in the current developing era of balloon-assisted enteroscopy.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: TC LEE, MD
- Email: johnlee0212@gmail.com
Study Locations
-
-
-
Kaohsiung, Taiwan
- Recruiting
- E-DA Hospital
-
Contact:
- CM Tai, MD
- Email: chimingtai@gmail.com
-
Principal Investigator:
- CM Tai, MD
-
Taipei, Taiwan, 100
- Recruiting
- NTUH
-
Contact:
- TC LEE, MD
- Email: johnlee0212@gmail.com
-
Principal Investigator:
- TC Lee, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
tertiary medical center,patients with clinical presentation necessitating deep enteroscopy examinations.
Description
Inclusion Criteria:
- adult patients with clinical suspicions of small intestinal lesions in need of balloon-assisted enteroscopy examinations
- signed written informed consents
Exclusion Criteria:
- Patients with active infection or receiving systemic (oral or intravenous) antibiotics within recent 3 months (this may decrease effect of bacterial translocation) or taking drugs that may affect renal function within 3 months
- Unstable health condition for balloon-assisted enteroscopy (unstable hemodynamics, severe cardiopulmonary compromise)
- Pregnancy
- known allergy to lactulose, mannitol
- Refuse to sign written informed consent of this study.
- patients would be advised to hold prokinetic agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Anally inserted enteroscopy group
|
Orally inserted enteroscopy group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
molecular bacteremia
Time Frame: 7d
|
7d
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: TC Lee, MD, NTUH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
February 8, 2010
First Submitted That Met QC Criteria
February 8, 2010
First Posted (Estimate)
February 9, 2010
Study Record Updates
Last Update Posted (Estimate)
February 9, 2010
Last Update Submitted That Met QC Criteria
February 8, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200812154R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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