Microbiome Changes in Travelers to Tropical Destinations

October 3, 2017 updated by: Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Recruiting
        • Center of Geographic Medicine
        • Contact:
        • Principal Investigator:
          • Eli Schwartz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Travelers who intended to travel to tropical areas.

Description

Inclusion Criteria:

  • Travelers who intended to travel to tropical areas
  • Good general health

Exclusion Criteria:

  • Medication consumption
  • Background diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type and number of intestinal microorganisms
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Weizmann Institute of Science

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-1543-ES-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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