DysbiosisABROADNCT03043300
A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US
An observational study of Dysbiosis, run by Emory University at 2 sites in United States.
Trial summary
This prospective, observational pilot study is designed to assess feasibility, refine the target population, and quickly test qualitative and quantitative changes in the microbiome after short-term travel to South or Southeast Asia, regions where rates of travelers' diarrhea and intestinal colonization with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis
- What is being tested?
- Screening Criteria Review, Pre-Travel Questionnaire and Pre-Travel Stool Specimen Collection
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2017to 1 Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emory University students and/or Emory University Hospital's TravelWell Center patients with international travel plans
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document.
- Ability and willingness to comply with study protocol requirements.
- Completed screening criteria.
- Departure date for international travel is planned for 4 weeks from the date of informed consent.
- Duration of international travel is planned for a minimum of seven days and maximum of 21 days.
- International travel is planned to at least one of the following countries of South(east) Asia:
- South Asia, defined as: Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka
- Southeast Asia, defined as: Cambodia, Laos, West Malaysia (excluding Malaysian Borneo), Myanmar (Burma), Thailand, Vietnam
Who cannot join
- Women of childbearing potential who self-report to be either:
- Currently pregnant
- Planning a pregnancy during study participation
- Current diarrhea (defined as ≥ 3 unformed loose stools in 24 hours)
- Prior episode of diarrhea (defined as ≥ 3 unformed loose stools in 24 hours) in the 12 weeks prior to date of informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Univeristy Hospital Midtown, TravelWell Center
Atlanta, Georgia, 30308
Emory University
Atlanta, Georgia, 30322
About this study
Official title: A Pilot Study to Assess the Intestinal MicroBiota Diversification States and Changes in U.S. Travelers After Return From Short-Term Travel to an Overseas South(East) Asian Destination
This prospective, observational pilot study is designed to assess feasibility, refine the target population, and quickly test qualitative and quantitative changes in the microbiome after short-term travel to South or Southeast Asia, regions where rates of travelers' diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.
To measure the diversity change of the intestinal microbiota, participants will complete a questionnaire and provide a stool specimen at three different time points: prior to traveling, two weeks after returning from traveling, and 14 weeks after returning from traveling.
Read the detailed description
Travelers' diarrhea is the most common illness experienced by those going overseas. Estimates vary, but incidence has been reported to range between 30-60%, depending on travel destination and season. Multiple organisms have been implicated as causes of travelers' diarrhea, but bacteria account for 80-90% of cases. There is mounting evidence that the integrity of the intestinal microbiome may be a strong modulator of diarrheal disease, and that intestinal infections and other factors, including stress, antibiotic exposure, and diet may disrupt the diversity and overall composition of the microbiome. Dysbiosis, a state of altered microbiota diversity, may be less resistant to the acquisition of intestinal pathogens and colonization of multiple drug resistant organisms. Furthermore, disruptions in the microbiome that may result from an episode of travelers' diarrhea may have a role in the development of chronic diarrhea and post-infectious irritable bowel syndrome.
This prospective, observational pilot study is intended to obtain preliminary data to support the rationale for a subsequent larger cohort study. This study is designed to assess feasibility, refine the target population, and quickly test qualitative and quantitative changes in the microbiome after short-term travel (seven to 21 days) to South or Southeast Asia, regions where rates of travelers' diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.
The target population will include 10 Emory University students and/or Emory University Hospital TravelWell Clinic (TWC) patients who have international travel plans. Consented, willing, and eligible participants will complete an initial eligibility screening, followed by pre-travel, short-term post-travel, and long-term post-travel study visits. To determine specific factors associated with diversity change of the intestinal microbiota and changes in the presence of genes that code for antibiotic resistance, questionnaires designed to collect data on demographics, medical history, diet, food intake, recent (within 12 weeks of pre-travel assessment, during travel, or post-travel) illness history, medication use, travel itinerary, travel activities, and relevant food and water risk behaviors will be completed at each study visit. A stool sample will also be provided at each time point. Participants may also choose to take part in an optional sub-study which involves banking leftover stool for future research use.
The primary protocol objective is to pilot a study investigating the association between travel and changes in the intestinal microbiome (including both bacterial and fungal components) and the bacterial and fungal resistome.
The secondary protocol objective is to assess microbiota profile changes and reversion to or toward the pre-travel state by comparing pre-travel stool specimen sequencing results to short-term post-travel and long-term post-travel stool specimen sequencing results.
- Conditions
- Dysbiosis
- Being tested
- Screening Criteria Review, Pre-Travel Questionnaire, Pre-Travel Stool Specimen Collection, Short-Term Post-Travel Questionnaire, Short-Term Post-Travel Stool Specimen Collection
- Keywords
- Travelers' diarrhea, Intestinal microbiota, Antibiotic resistance, Antibiotics, Gastrointestinal disorders, Infectious diseases, International Travel, Travel Medicine, Resistome, Microbiome
- Medical subject headings
- Dysbiosis, Gastrointestinal Diseases, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening Criteria ReviewOther
Also called Appendix A
The screening criteria review is an 8 item instrument collecting information during screening about overall health, including self-reported chronic intestinal conditions, immunocompromising conditions, the use of certain medication types (immunosuppressives and antibiotics), and pregnancy status. The instrument will also collect dates of planned travel to South(east) as well as preferred dates for study visits and reminder contacts.
This instrument will be administered verbally by the study team and completed no more than 4 weeks prior to travel departure from the United States.
Pre-Travel QuestionnaireOther
Also called Appendix C
The pre-travel questionnaire is a 29 item instrument collecting information about baseline characteristics, dietary habits, travel plans, and health history.
This questionnaire will be administered verbally by the study team and completed 1 week prior to travel departure from the United States.
Pre-Travel Stool Specimen CollectionOther
The pre-travel stool specimen collection will occur 1 week prior to travel departure from the United States.
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.
Short-Term Post-Travel QuestionnaireOther
Also called Appendix D
The short-term post-travel questionnaire is a 19 item instrument collecting information about dates and locations of travel, food and beverages consumed while traveling, and illnesses during or following traveling.
This questionnaire will be administered verbally by the study team and completed 2 weeks after returning to the United States from travel.
Short-Term Post-Travel Stool Specimen CollectionOther
The short-term post-travel stool specimen collection will occur 2 weeks after returning to the United States from travel.
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.
Long-Term Post-Travel QuestionnaireOther
Also called Appendix E
The long-term post-travel questionnaire is a 16 item instrument collecting information about illnesses since last study visit, dietary habits since last study visit, and any traveling since the last visit.
This questionnaire will be administered verbally by the study team and completed 14 weeks after returning to the United States from travel.
Long-Term Post-Travel Stool Specimen CollectionOther
The short-term post-travel stool specimen collection will occur 14 weeks after returning to the United States from travel.
The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention.
| Study group | Role | What they receive |
|---|---|---|
| US Travelers to South or Southeast Asia | Adult individuals who are planning a short term trip to South or Southeast Asia and meet all eligibility criteria will complete the questionnaires and/or provide stool specimens at the following time points:
1. No greater than 4 weeks prior to travel departure: Screening Criteria Review
2. One week prior to travel departure: Pre-Travel Questionnaire and Pre-Travel Stool Specimen Collection
3. Two weeks after return from travel: Short-Term Post-Travel Questionnaire and Short-Term Post-Travel Stool Specimen Collection
4. 14 weeks after return from travel: Long-Term Post-Travel Questionnaire and Long-Term Post-Travel Stool Specimen Collection Receives: Other: Screening Criteria Review; Other: Pre-Travel Questionnaire; Other: Pre-Travel Stool Specimen Collection; Other: Short-Term Post-Travel Questionnaire; Other: Short-Term Post-Travel Stool Specimen Collection; Other: Long-Term Post-Travel Questionnaire; Other: Long-Term Post-Travel Stool Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Predominant Intestinal Microbiota Genus or Strain
A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.
Measured: Pre-travel to 14 Weeks Post-Travel
Change in Alpha and Beta Diversity of Intestinal Microbiota
Maximum percentage of all genes identified included within the same taxon will be determined from each stool sample.
Measured: Pre-travel to 14 Weeks Post-Travel
Change in Firmicutes:Bacteroides Ratio of Microbiota
Firmicutes and Bacteroides are groups of bacteria present in the gut and the Firmicutes to Bacteroidetes ratio is considered a significant aspect of microbiota composition. The Firmicutes to Bacteroidetes ratio will be determined from each stool sample.
Measured: Pre-travel to 14 Weeks Post-Travel
Change in Enteropathogens of Stool Microbiota
The presence of enteropathogens in stool samples will be examined pre- and post-travel.
Measured: Pre-travel to 14 Weeks Post-Travel
Change in Stool Resistome
Review of the resistome will include a summary of the overall number and diversity of bacterial and fungal resistance genes including any new acquisition.
Measured: Pre-travel to 14 Weeks Post-Travel
Secondary outcomes (1)
Reversion toward pre-travel microbiota state
Microbiota profile changes and reversion to or toward the pre-travel state will be assessed by comparing pre-travel stool specimen sequencing results to short-term post-travel and long-term post-travel stool specimen sequencing results.
Measured: Pre-travel to 14 Weeks Post-Travel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start7 Nov 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Colleen S Kraft, MD, MSc, Emory University
- Investigators
- Colleen S Kraft, MD, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043300
- Sponsor's protocol ID
- IRB00092426
- Other IDs
- 16IPA1609428
- Acronym
- ABROAD
- Status last verified
- Jan 2019
- First submitted
- 2 Feb 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Intestinal MicroBiota Diversification States and Changes in U.S. Travelers After Return From Short-Term Travel to an Overseas South(East) Asian Destination
- ClinicalTrials.gov ID
- NCT03043300
- Acronym / sponsor ID
- ABROAD / IRB00092426
- Conditions
- Dysbiosis
- Keywords
- Travelers' diarrhea, Intestinal microbiota, Antibiotic resistance, Antibiotics, Gastrointestinal disorders, Infectious diseases, International Travel, Travel Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 6 Feb 2017 (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.
This prospective, observational pilot study is designed to assess feasibility, refine the target population, and quickly test qualitative and quantitative changes in the microbiome after short-term travel to South or Southeast Asia, regions where rates of travelers' diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.
To measure the diversity change of the intestinal microbiota, participants will complete a questionnaire and provide a stool specimen at three different time points: prior to traveling, two weeks after returning from traveling, and 14 weeks after returning from traveling.
Detailed description
Travelers' diarrhea is the most common illness experienced by those going overseas. Estimates vary, but incidence has been reported to range between 30-60%, depending on travel destination and season. Multiple organisms have been implicated as causes of travelers' diarrhea, but bacteria account for 80-90% of cases. There is mounting evidence that the integrity of the intestinal microbiome may be a strong modulator of diarrheal disease, and that intestinal infections and other factors, including stress, antibiotic exposure, and diet may disrupt the diversity and overall composition of the microbiome. Dysbiosis, a state of altered microbiota diversity, may be less resistant to the acquisition of intestinal pathogens and colonization of multiple drug resistant organisms. Furthermore, disruptions in the microbiome that may result from an episode of travelers' diarrhea may have a role in the development of chronic diarrhea and post-infectious irritable bowel syndrome.
This prospective, observational pilot study is intended to obtain preliminary data to support the rationale for a subsequent larger cohort study. This study is designed to assess feasibility, refine the target population, and quickly test qualitative and quantitative changes in the microbiome after short-term travel (seven to 21 days) to South or Southeast Asia, regions where rates of travelers' diarrhea and intestinal colonization with antimicrobial resistant bacteria are highest.
The target population will include 10 Emory University students and/or Emory University Hospital TravelWell Clinic (TWC) patients who have international travel plans. Consented, willing, and eligible participants will complete an initial eligibility screening, followed by pre-travel, short-term post-travel, and long-term post-travel study visits. To determine specific factors associated with diversity change of the intestinal microbiota and changes in the presence of genes that code for antibiotic resistance, questionnaires designed to collect data on demographics, medical history, diet, food intake, recent (within 12 weeks of pre-travel assessment, during travel, or post-travel) illness history, medication use, travel itinerary, travel activities, and relevant food and water risk behaviors will be completed at each study visit. A stool sample will also be provided at each time point. Participants may also choose to take part in an optional sub-study which involves banking leftover stool for future research use.
The primary protocol objective is to pilot a study investigating the association between travel and changes in the intestinal microbiome (including both bacterial and fungal components) and the bacterial and fungal resistome.
The secondary protocol objective is to assess microbiota profile changes and reversion to or toward the pre-travel state by comparing pre-travel stool specimen sequencing results to short-term post-travel and long-term post-travel stool specimen sequencing results.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US Travelers to South or Southeast Asia | – | Other: Screening Criteria Review, Other: Pre-Travel Questionnaire, Other: Pre-Travel Stool Specimen Collection, Other: Short-Term Post-Travel Questionnaire, Other: Short-Term Post-Travel Stool Specimen Collection, Other: Long-Term Post-Travel Questionnaire, Other: Long-Term Post-Travel Stool Specimen CollectionAdult individuals who are planning a short term trip to South or Southeast Asia and meet all eligibility criteria will complete the questionnaires and/or provide stool specimens at the following time points: 1. No greater than 4 weeks prior to travel departure: Screening Criteria Review 2. One week prior to travel departure: Pre-Travel Questionnaire and Pre-Travel Stool Specimen Collection 3. Two weeks after return from travel: Short-Term Post-Travel Questionnaire and Short-Term Post-Travel Stool Specimen Collection 4. 14 weeks after return from travel: Long-Term Post-Travel Questionnaire and Long-Term Post-Travel Stool Specimen Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emory University students and/or Emory University Hospital's TravelWell Center patients with international travel plans
Key inclusion criteria (8 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Ability and willingness to comply with study protocol requirements.
- Completed screening criteria.
- Departure date for international travel is planned for 4 weeks from the date of informed consent.
- Duration of international travel is planned for a minimum of seven days and maximum of 21 days.
Key exclusion criteria (5 listed)
- Women of childbearing potential who self-report to be either:
- Current diarrhea (defined as ≥ 3 unformed loose stools in 24 hours)
- Prior episode of diarrhea (defined as ≥ 3 unformed loose stools in 24 hours) in the 12 weeks prior to date of informed consent
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 |
|---|---|---|
| Screening Criteria ReviewAlso: Appendix AThe screening criteria review is an 8 item instrument collecting information during screening about overall health, including self-reported chronic intestinal conditions, immunocompromising conditions, the use of certain medication types (immunosuppressives and antibiotics), and pregnancy status. The instrument will also collect dates of planned travel to South(east) as well as preferred dates for study visits and reminder contacts. This instrument will be administered verbally by the study team and completed no more than 4 weeks prior to travel departure from the United States. | Other | US Travelers to South or Southeast Asia |
| Pre-Travel QuestionnaireAlso: Appendix CThe pre-travel questionnaire is a 29 item instrument collecting information about baseline characteristics, dietary habits, travel plans, and health history. This questionnaire will be administered verbally by the study team and completed 1 week prior to travel departure from the United States. | Other | US Travelers to South or Southeast Asia |
| Pre-Travel Stool Specimen CollectionThe pre-travel stool specimen collection will occur 1 week prior to travel departure from the United States. The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention. | Other | US Travelers to South or Southeast Asia |
| Short-Term Post-Travel QuestionnaireAlso: Appendix DThe short-term post-travel questionnaire is a 19 item instrument collecting information about dates and locations of travel, food and beverages consumed while traveling, and illnesses during or following traveling. This questionnaire will be administered verbally by the study team and completed 2 weeks after returning to the United States from travel. | Other | US Travelers to South or Southeast Asia |
| Short-Term Post-Travel Stool Specimen CollectionThe short-term post-travel stool specimen collection will occur 2 weeks after returning to the United States from travel. The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention. | Other | US Travelers to South or Southeast Asia |
| Long-Term Post-Travel QuestionnaireAlso: Appendix EThe long-term post-travel questionnaire is a 16 item instrument collecting information about illnesses since last study visit, dietary habits since last study visit, and any traveling since the last visit. This questionnaire will be administered verbally by the study team and completed 14 weeks after returning to the United States from travel. | Other | US Travelers to South or Southeast Asia |
| Long-Term Post-Travel Stool Specimen CollectionThe short-term post-travel stool specimen collection will occur 14 weeks after returning to the United States from travel. The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention. | Other | US Travelers to South or Southeast Asia |
Primary outcome
Change in Predominant Intestinal Microbiota Genus or Strain
Time frame: Pre-travel to 14 Weeks Post-Travel
A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.
Change in Alpha and Beta Diversity of Intestinal Microbiota
Time frame: Pre-travel to 14 Weeks Post-Travel
Maximum percentage of all genes identified included within the same taxon will be determined from each stool sample.
Change in Firmicutes:Bacteroides Ratio of Microbiota
Time frame: Pre-travel to 14 Weeks Post-Travel
Firmicutes and Bacteroides are groups of bacteria present in the gut and the Firmicutes to Bacteroidetes ratio is considered a significant aspect of microbiota composition. The Firmicutes to Bacteroidetes ratio will be determined from each stool sample.
Change in Enteropathogens of Stool Microbiota
Time frame: Pre-travel to 14 Weeks Post-Travel
The presence of enteropathogens in stool samples will be examined pre- and post-travel.
Change in Stool Resistome
Time frame: Pre-travel to 14 Weeks Post-Travel
Review of the resistome will include a summary of the overall number and diversity of bacterial and fungal resistance genes including any new acquisition.
1 secondary outcome
Reversion toward pre-travel microbiota state
Time frame: Pre-travel to 14 Weeks Post-Travel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Colleen S Kraft, MD, MSc principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysbiosis, run by Emory University at 2 sites in United States.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Predominant Intestinal Microbiota Genus or Strain (time frame: Pre-travel to 14 Weeks Post-Travel). The study lists 5 primary outcomes in all. 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 30 Jan 2019.