EnteritisNCT01065324
Balloon-assisted Enteroscopy and Bacteria
An observational study of Enteritis and Bleeding, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 2 sitesTaiwan
- Study dates
- Feb 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary medical center,patients with clinical presentation necessitating deep enteroscopy examinations.
Who may be able to join
- adult patients with clinical suspicions of small intestinal lesions in need of balloon-assisted enteroscopy examinations
- signed written informed consents
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
TC Lee, MD contact
Taiwan2 sites, 2 recruiting
- Recruiting
E-Da Hospital
Kaohsiung City
CM Tai, MD, chimingtai@gmail.com
CM Tai, MD
- Recruiting
NTUH
Taipei, 100
TC LEE, MD, johnlee0212@gmail.com
TC Lee, MD
About this study
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
- Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases.
- Deep enteroscopy made possible by balloon expansion and manipulation of small intestines.
- However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied.
- 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.
- Keywords
- balloon, enteroscopy, bacteremia
- Medical subject headings
- Enteritis, Hemorrhage, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anally inserted enteroscopy group | Anally inserted enteroscopy group | |
| Orally inserted enteroscopy group | Orally inserted enteroscopy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular bacteremia
Measured: 7d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnteritisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- TC Lee, MD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065324
- Sponsor's protocol ID
- 200812154R
- Status last verified
- Feb 2010
- First submitted
- 8 Feb 2010
- Last updated
- 9 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01065324
- Acronym / sponsor ID
- 200812154R
- Keywords
- balloon, enteroscopy, bacteremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases.
- Deep enteroscopy made possible by balloon expansion and manipulation of small intestines.
- However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied.
- We will also examine relevant patient factors.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anally inserted enteroscopy group | – | –Anally inserted enteroscopy group |
| Orally inserted enteroscopy group | – | –Orally inserted enteroscopy group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary medical center,patients with clinical presentation necessitating deep enteroscopy examinations.
Key inclusion criteria (2 listed)
- adult patients with clinical suspicions of small intestinal lesions in need of balloon-assisted enteroscopy examinations
- signed written informed consents
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
molecular bacteremia
Time frame: 7d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TC Lee, MD contact
TC Lee, MD principal investigator
NTUH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteritis and Bleeding, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TC Lee, MD (johnlee0212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
molecular bacteremia (time frame: 7d). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2010.