Balloon-assisted Enteroscopy and Bacteria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

Brief Summary:
  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.

Condition or disease
Enteritis Bleeding

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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intestinal Barrier Permeability Defects, Recovery, and Risk of Bacterial Translocation Induced After Deep Intestinal Manipulation by Balloon-assisted Enteroscopy: From Basic to Clinical Research
Study Start Date : February 2010
Estimated Study Completion Date : December 2012

Anally inserted enteroscopy group
Anally inserted enteroscopy group
Orally inserted enteroscopy group
Orally inserted enteroscopy group

Primary Outcome Measures :
  1. molecular bacteremia [ Time Frame: 7d ]

Biospecimen Retention:   Samples With DNA
Bacterial DNA, host DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
tertiary medical center,patients with clinical presentation necessitating deep enteroscopy examinations.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065324

Contact: TC Lee, MD

E-Da Hospital Recruiting
Kaohsiung, Taiwan
Contact: CM Tai, MD   
Principal Investigator: CM Tai, MD         
NTUH Recruiting
Taipei, Taiwan, 100
Contact: TC LEE, MD   
Principal Investigator: TC Lee, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: TC Lee, MD NTUH

Responsible Party: NTUH Identifier: NCT01065324     History of Changes
Other Study ID Numbers: 200812154R
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: February 2010

Keywords provided by National Taiwan University Hospital:

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases