Microbiome Changes in Travelers to Tropical Destinations

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02295254

Collaborator

Weizmann Institute of Science (Other)

100

Enrollment

Location

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Diseases	Other: feces sample

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Microbiome Changes in Travelers to Tropical Destinations

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 The travelers will give feces sample before and after the travel. The sample microorganisms will be analyzed.

Arm

Intervention/Treatment

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

The travelers will give feces sample before and after the travel. The sample microorganisms will be analyzed.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Travelers who intended to travel to tropical areas
Good general health

Exclusion Criteria:

Medication consumption
Background diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Geographic Medicine	Tel Hashomer		Israel

Sponsors and Collaborators

Sheba Medical Center
Weizmann Institute of Science

Investigators

Principal Investigator: Eli Schwartz, MD, DTMH, Eli.schwartz@sheba.health.gov.il

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02295254

Other Study ID Numbers:

SHEBA-14-1543-ES-CTIL

First Posted:

Nov 20, 2014

Last Update Posted:

Oct 4, 2017

Last Verified:

Oct 1, 2017

Additional relevant MeSH terms:

Intestinal Diseases

Study Results

No Results Posted as of Oct 4, 2017