ClinicalTrials.gg
Status unknownNCT01065324Updated Feb 9, 2010

Balloon-assisted Enteroscopy and Bacteria

An observational study in Enteritis and Bleeding, sponsored by National Taiwan University Hospital. Status unknown at 2 sites in Taiwan. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-09.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Enteritis
  • Bleeding

Keywords

  • balloon
  • enteroscopy
  • bacteremia
03

In context

Enteritis

34 studies on the registry are indexed under Enteritis; 7 are open to participants now.

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Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patients with clinical suspicions of small intestinal lesions in need of balloon-assisted enteroscopy examinations
  • signed written informed consents

Exclusion criteria

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 of this study.
  • patients would be advised to hold prokinetic agents
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Anally inserted enteroscopy group

    Anally inserted enteroscopy group

  • Orally inserted enteroscopy group

    Orally inserted enteroscopy group

06

What researchers measure

Primary outcomes

  1. molecular bacteremia

    Time frame: 7d

07

Study locations

2 of 2 sites recruiting
  • E-Da Hospital
    Kaohsiung, Taiwan
    Recruiting
  • NTUH
    Taipei, 100, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01065324
First posted
Feb 9, 2010
Start date
Feb 2010
Completion
Dec 2012 (estimated)
Last update
Feb 9, 2010

Study contacts

TC Lee, MD
Contact
johnlee0212@gmail.com
TC Lee, MD
principal investigator · NTUH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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