NCT03043300

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

February 2, 2017

Last Update Submit

January 29, 2019

Conditions

Dysbiosis

Keywords

Travelers' diarrheaIntestinal microbiotaAntibiotic resistanceAntibioticsGastrointestinal disordersInfectious diseasesInternational TravelTravel MedicineResistomeMicrobiome

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Pre-travel to 14 Weeks Post-Travel

Secondary Outcomes (1)

  • Reversion toward pre-travel microbiota state

    Pre-travel to 14 Weeks Post-Travel

Study Arms (1)

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

Other: Screening Criteria ReviewOther: Pre-Travel QuestionnaireOther: Pre-Travel Stool Specimen CollectionOther: Short-Term Post-Travel QuestionnaireOther: Short-Term Post-Travel Stool Specimen CollectionOther: Long-Term Post-Travel QuestionnaireOther: Long-Term Post-Travel Stool Specimen Collection

Interventions

Screening Criteria ReviewOTHER

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.

Also known as: Appendix A
US Travelers to South or Southeast Asia
Pre-Travel QuestionnaireOTHER

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.

Also known as: Appendix C
US Travelers to South or Southeast Asia
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.

US Travelers to South or Southeast Asia
Short-Term Post-Travel QuestionnaireOTHER

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.

Also known as: Appendix D
US Travelers to South or Southeast Asia
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.

US Travelers to South or Southeast Asia
Long-Term Post-Travel QuestionnaireOTHER

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.

Also known as: Appendix E
US Travelers to South or Southeast Asia
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.

US Travelers to South or Southeast Asia

Eligibility Criteria

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

Emory University students and/or Emory University Hospital's TravelWell Center patients with international travel plans

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory Univeristy Hospital Midtown, TravelWell Center

Atlanta, Georgia, 30308, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Every stool specimen will be collected by the participant and placed in a kit and stored for deoxyribonucleic acid (DNA) extraction and sequencing. Specimens will be batched for analysis.

MeSH Terms

Conditions

DysbiosisGastrointestinal DiseasesCommunicable Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System DiseasesInfectionsDisease Attributes

Study Officials

  • Colleen S Kraft, MD, MSc

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 6, 2017

Study Start

November 7, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)