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NCT02295254 Clinical Trial

Microbiome Changes in Travelers to Tropical Destinations

Intestinal Diseases Clinical Trial

Official title:
Microbiome Changes in Travelers to Tropical Destinations

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02295254
Other study ID # SHEBA-14-1543-ES-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received November 11, 2014
Last updated October 3, 2017
Start date September 2014
Est. completion date January 2019

Study information
Verified date October 2017
Source Sheba Medical Center
Contact Eli Schwartz, MD, DTMH
Email Eli.schwartz@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 2019
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Travelers who intended to travel to tropical areas

- Good general health

Exclusion Criteria:

- Medication consumption

- Background diseases

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Center of Geographic Medicine Tel Hashomer

Sponsors (2)
Lead Sponsor Collaborator
Sheba Medical Center Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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