NCT01945723

Brief Summary

Tissue characterization will be performed, from different regions of the gastrointestinal tract in healthy volunteers.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

September 15, 2013

Last Update Submit

September 17, 2013

Conditions

Healthy

Keywords

EndoscopyGastrointestinal tractBacterial markersvolunteers

Outcome Measures

Primary Outcomes (1)

  • Bacterial markers in different intestinal segments.

    1 year

Study Arms (1)

Healthy volunteers

Healthy volunteers

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

10 healthy volunteers

You may qualify if:

  • Healthy volunteers,
  • Age: 20-60 years,
  • Consent to perform endoscopic examination.

You may not qualify if:

  • Antibiotics - a month prior to participation in the study,
  • A chronic health condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroentherology

Tel Aviv, 64239, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue, liquid and stool samples from Gastrointestinal tract.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2013

First Posted

September 18, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

October 1, 2015

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

IL(1)