Microbiome Changes in Travelers to Tropical Destinations | NCT02295254

Studies
Microbiome Changes in Travelers to Tropical Destinations

NCT02295254

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Oct 4, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Intestinal Diseases

Interventions

feces sample

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

Oct 2017

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 2014

Primary Completion Date

Sep 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Nov 11, 2014

First Submission Date that Met QC Criteria

Nov 17, 2014

First Posted Date

Nov 20, 2014Estimated

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

Oct 3, 2017

Last Update Posted Date

Oct 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Eli Schwartz MD, DTMH, Principal Investigator of geographic clinic, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Name	Class
Weizmann Institute of Science	OTHER

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

The human gut contain a wide range of microorganisms creating the gut microbiome. The microbiome has great impact on metabolic and immunologic processes and responses. Travelers who travel to tropical destinations where the intestinal infection risk is high are prone to microbiome changes. During the current study the travelers will give feces specimen before and after the travel and their microbiome will be analyzed.

Detailed Description

Individual differences in the microorganisms variety are affected by external factors such as food, age, geographic location, medication consumption, host genetics and exposure to microorganisms in early stages of life. During the current study the geographic location affect will be tested by comparing the microorganism environment before and after traveling to tropical destinations.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Research group		The study contain only one group: travelers who intended to travel to tropical destinations. The participants will give a feces sample before and after the travel.	Other: feces sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
feces sample	Other	The travelers will give feces sample before and after the travel. The sample microorganisms will be analyzed.	Research group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type and number of intestinal microorganisms	The participants microbiome will be analyzed before and after the travel. The type and number of microorganisms will be determined by microbiological measurements.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Travelers who intended to travel to tropical areas
Good general health

Exclusion Criteria:

Medication consumption
Background diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Travelers who intended to travel to tropical areas.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eli Schwartz, MD, DTMH	Contact			Eli.schwartz@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Eli Schwartz, MD, DTMH	Eli.schwartz@sheba.health.gov.il	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Geographic Medicine	Recruiting	Tel Litwinsky			Israel

Condition Browse Module

MeSH Terms

ID	Term
D007410	Intestinal Diseases

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided