Tissue Characterization From Various Parts of the Gastroi... | NCT01945723

Studies
Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers

NCT01945723

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Sep 18, 2013Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Sep 15, 2013

First Submission Date that Met QC Criteria

Sep 17, 2013

First Posted Date

Sep 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2013

Last Update Posted Date

Sep 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

During an endoscopic examination tissue samples will be taken from different regions of the gastrointestinal mucosa. The tissue samples will be used to characterize bacterial markers in the various intestinal segments.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Estimated

Label	Type	Description	Intervention Names
Healthy volunteers		Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bacterial markers in different intestinal segments.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

10 healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroentherology	Recruiting	Tel Aviv		64239	Israel