Intestinal DiseasesNCT02295254
Microbiome Changes in Travelers to Tropical Destinations
An observational study of Intestinal Diseases, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Diseases
- What is being tested?
- feces sample
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Travelers who intended to travel to tropical areas.
Who may be able to join
- Travelers who intended to travel to tropical areas
- Good general health
Who cannot join
- Medication consumption
- Background diseases
Trial locations and contacts
1 site in 1 country.
Eli Schwartz, MD, DTMH contact
Israel1 site, 1 recruiting
- Recruiting
Center of Geographic Medicine
Tel HaShomer
eli Schwartz, MD, 03-5302422, elischwa@post.tau.ac.il
Eli Schwartz, MD
About this study
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.
Read the 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.
- Conditions
- Intestinal Diseases
- Being tested
- feces sample
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feces sampleOther
The travelers will give feces sample before and after the travel. The sample microorganisms will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: feces sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
- Investigators
- Eli Schwartz, MD, DTMH, Principal investigator, Eli.schwartz@sheba.health.gov.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295254
- Sponsor's protocol ID
- SHEBA-14-1543-ES-CTIL
- Status last verified
- Oct 2017
- First submitted
- 11 Nov 2014
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Changes in Travelers to Tropical Destinations
- ClinicalTrials.gov ID
- NCT02295254
- Acronym / sponsor ID
- SHEBA-14-1543-ES-CTIL
- Conditions
- Intestinal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Weizmann Institute of Science
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research group | – | Other: feces sampleThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Travelers who intended to travel to tropical areas.
Key inclusion criteria (2 listed)
- Travelers who intended to travel to tropical areas
- Good general health
Key exclusion criteria (2 listed)
- Medication consumption
- Background diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| feces sampleThe travelers will give feces sample before and after the travel. The sample microorganisms will be analyzed. | Other | Research group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
Related trials for Intestinal Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli Schwartz, MD, DTMH contact
Eli Schwartz, MD, DTMH principal investigator
Eli.schwartz@sheba.health.gov.il
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Diseases, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eli Schwartz, MD, DTMH (Eli.schwartz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type and number of intestinal microorganisms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.