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Balloon-assisted Enteroscopy and Bacteria

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ClinicalTrials.gov Identifier: NCT01065324
Recruitment Status : Unknown
Verified February 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : February 9, 2010
Last Update Posted : February 9, 2010
Information provided by:
National Taiwan University Hospital

February 8, 2010
February 9, 2010
February 9, 2010
February 2010
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molecular bacteremia [ Time Frame: 7d ]
Same as current
No Changes Posted
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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 Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Bacterial DNA, host DNA
Probability Sample
tertiary medical center,patients with clinical presentation necessitating deep enteroscopy examinations.
  • Enteritis
  • Bleeding
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  • Anally inserted enteroscopy group
    Anally inserted enteroscopy group
  • Orally inserted enteroscopy group
    Orally inserted enteroscopy group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2012
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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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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National Taiwan University Hospital
Not Provided
Principal Investigator: TC Lee, MD NTUH
National Taiwan University Hospital
February 2010