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Balloon-assisted Enteroscopy and Bacteria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01065324
First received: February 8, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 8, 2010
February 8, 2010
February 2010
Not Provided
molecular bacteremia [ Time Frame: 7d ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Balloon-assisted Enteroscopy and Bacteria
Intestinal Barrier Permeability Defects, Recovery, and Risk of Bacterial Translocation Induced After Deep Intestinal Manipulation by Balloon-assisted Enteroscopy: From Basic to Clinical Research
  1. Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases.
  2. Deep enteroscopy made possible by balloon expansion and manipulation of small intestines.
  3. However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied.
  4. We will also examine relevant patient factors.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Bacterial DNA, host DNA

Probability Sample

tertiary medical center,patients with clinical presentation necessitating deep enteroscopy examinations.

  • Enteritis
  • Bleeding
Not Provided
  • Anally inserted enteroscopy group
    Anally inserted enteroscopy group
  • Orally inserted enteroscopy group
    Orally inserted enteroscopy group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2012
Not Provided

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
Both
18 Years to 90 Years
Yes
Contact: TC Lee, MD johnlee0212@gmail.com
Taiwan
 
NCT01065324
200812154R
Yes
NTUH
National Taiwan University Hospital
Not Provided
Principal Investigator: TC Lee, MD NTUH
National Taiwan University Hospital
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP