Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose
  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
Enteritis
Bleeding

Study Type: Observational
Study Design: 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

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • molecular bacteremia [ Time Frame: 7d ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Bacterial DNA, host DNA


Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Groups/Cohorts
Anally inserted enteroscopy group
Anally inserted enteroscopy group
Orally inserted enteroscopy group
Orally inserted enteroscopy group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065324

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

Locations
Taiwan
E-Da Hospital Recruiting
Kaohsiung, Taiwan
Contact: CM Tai, MD       chimingtai@gmail.com   
Principal Investigator: CM Tai, MD         
NTUH Recruiting
Taipei, Taiwan, 100
Contact: TC LEE, MD       johnlee0212@gmail.com   
Principal Investigator: TC Lee, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: TC Lee, MD NTUH
  More Information

No publications provided

Responsible Party: NTUH
ClinicalTrials.gov Identifier: NCT01065324     History of Changes
Other Study ID Numbers: 200812154R
Study First Received: February 8, 2010
Last Updated: February 8, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
balloon
enteroscopy
bacteremia

ClinicalTrials.gov processed this record on November 25, 2014