NCT01065324

Brief Summary

  1. 1.Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases.
  2. 2.Deep enteroscopy made possible by balloon expansion and manipulation of small intestines.
  3. 3.However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied.
  4. 4.We will also examine relevant patient factors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 9, 2010

Status Verified

February 1, 2010

First QC Date

February 8, 2010

Last Update Submit

February 8, 2010

Conditions

EnteritisBleeding

Keywords

balloonenteroscopybacteremia

Outcome Measures

Primary Outcomes (1)

  • molecular bacteremia

    7d

Study Arms (2)

Anally inserted enteroscopy group

Anally inserted enteroscopy group

Orally inserted enteroscopy group

Orally inserted enteroscopy group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

E-Da Hospital

Kaohsiung City, Taiwan

RECRUITING

NTUH

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA, host DNA

MeSH Terms

Conditions

EnteritisHemorrhageBacteremia

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammation

Study Officials

  • TC Lee, MD

    NTUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TC Lee, MD

CONTACT

johnlee0212@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

February 1, 2010

Study Completion

December 1, 2012

Last Updated

February 9, 2010

Record last verified: 2010-02

Locations

TW(2)