Balloon-assisted Enteroscopy and Bacteria

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”

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.

Arms, Groups and Cohorts in this Clinical Trial

• : Anally inserted enteroscopy group
  • Anally inserted enteroscopy group
• : Orally inserted enteroscopy group
  • Orally inserted enteroscopy group

Primary Measures

• molecular bacteremia
  • Time Frame: 7d
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: National Taiwan University Hospital Other

Overall Clinical Trial Officials and Contacts

TC Lee, MD Principal Investigator NTUH  

Overall Contact: TC Lee, MD  johnlee0212@gmail.com

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01065324

Study ID Number: 200812154R

ClinicalTrials.gov Identifier: NCT01065324

Health Authority: Taiwan: Department of Health