NCT02295254

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

November 11, 2014

Last Update Submit

October 3, 2017

Conditions

Intestinal Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

feces sampleOTHER

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

Research group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Travelers who intended to travel to tropical areas.

You may qualify if:

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

You may not qualify if:

  • Medication consumption
  • Background diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Geographic Medicine

Tel Litwinsky, Israel

RECRUITING

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Eli Schwartz, MD, DTMH

    Eli.schwartz@sheba.health.gov.il

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Schwartz, MD, DTMH

CONTACT

Eli.schwartz@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of geographic clinic

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 20, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

January 1, 2019

Last Updated

October 4, 2017

Record last verified: 2017-10

Locations

IL(1)