Bleeding Clinical Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2012 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Taiwan | E-Da Hospital | Kaohsiung | |
Taiwan | NTUH | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | molecular bacteremia | 7d | Yes |
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