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Microbiome Changes in Travelers to Tropical Destinations

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ClinicalTrials.gov Identifier: NCT02295254
Recruitment Status : Recruiting
First Posted : November 20, 2014
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, Sheba Medical Center

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
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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiome Changes in Travelers to Tropical Destinations
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Travelers who intended to travel to tropical areas.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Medication consumption
  • Background diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295254


Contacts
Contact: Eli Schwartz, MD, DTMH Eli.schwartz@sheba.health.gov.il

Locations
Israel
Center of Geographic Medicine Recruiting
Tel Hashomer, Israel
Contact: eli Schwartz, MD    03-5302422    elischwa@post.tau.ac.il   
Principal Investigator: Eli Schwartz, MD         
Sponsors and Collaborators
Sheba Medical Center
Weizmann Institute of Science
Investigators
Principal Investigator: Eli Schwartz, MD, DTMH Eli.schwartz@sheba.health.gov.il

Responsible Party: Prof. Eli Schwartz MD, DTMH, Principal Investigator of geographic clinic, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02295254     History of Changes
Other Study ID Numbers: SHEBA-14-1543-ES-CTIL
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases