- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02295254
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
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 Contact
- Name: Eli Schwartz, MD, DTMH
- Email: Eli.schwartz@sheba.health.gov.il
Study Locations
-
-
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Tel Hashomer, Israel
- Recruiting
- Center of Geographic Medicine
-
Contact:
- eli Schwartz, MD
- Phone Number: 03-5302422
- Email: elischwa@post.tau.ac.il
-
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.
|
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
Collaborators
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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