A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US

NCT ID: NCT03043300

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2018-12-01

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Screening Criteria Review

Intervention Type: OTHER

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 Questionnaire

Intervention Type: OTHER

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 Collection

Intervention Type: OTHER

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 Questionnaire

Intervention Type: OTHER

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 Collection

Intervention Type: OTHER

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 Questionnaire

Intervention Type: OTHER

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 Collection

Intervention Type: OTHER

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.

Interventions

Screening Criteria Review

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.

Intervention Type: OTHER

Pre-Travel Questionnaire

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.

Intervention Type: OTHER

Pre-Travel Stool Specimen Collection

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.

Intervention Type: OTHER

Short-Term Post-Travel Questionnaire

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.

Intervention Type: OTHER

Short-Term Post-Travel Stool Specimen Collection

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.

Intervention Type: OTHER

Long-Term Post-Travel Questionnaire

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.

Intervention Type: OTHER

Long-Term Post-Travel Stool Specimen Collection

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.

Intervention Type: OTHER

Other Intervention Names

Appendix A; Appendix C; Appendix D; Appendix E

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and the willingness to sign a written informed consent document.

2. Ability and willingness to comply with study protocol requirements.

3. Completed screening criteria.

4. Departure date for international travel is planned for 4 weeks from the date of informed consent.

5. Duration of international travel is planned for a minimum of seven days and maximum of 21 days.

6. International travel is planned to at least one of the following countries of South(east) Asia:

1. South Asia, defined as: Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka

2. Southeast Asia, defined as: Cambodia, Laos, West Malaysia (excluding Malaysian Borneo), Myanmar (Burma), Thailand, Vietnam

Exclusion Criteria

1. Women of childbearing potential who self-report to be either:

1. Currently pregnant

2. Planning a pregnancy during study participation

2. Current diarrhea (defined as ≥ 3 unformed loose stools in 24 hours)

3. Prior episode of diarrhea (defined as ≥ 3 unformed loose stools in 24 hours) in the 12 weeks prior to date of informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Colleen S Kraft, MD, MSc

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colleen S Kraft, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Univeristy Hospital Midtown, TravelWell Center

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

16IPA1609428

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00092426

Identifier Type: -

Identifier Source: org_study_id