Clinical trial NCT03043300: A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysbiosis
Keywords: Travelers' diarrhea
Intestinal microbiota
Antibiotic resistance
Antibiotics
Gastrointestinal disorders
Infectious diseases
International Travel
Travel Medicine
Resistome
Microbiome
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2017-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emory University students and/or Emory University Hospital's TravelWell Center patients with international travel plans

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.

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

Primary outcomes:
measure: Change in Predominant Intestinal Microbiota Genus or Strain
timeFrame: Pre-travel to 14 Weeks Post-Travel
measure: Change in Alpha and Beta Diversity of Intestinal Microbiota
timeFrame: Pre-travel to 14 Weeks Post-Travel
measure: Change in Firmicutes:Bacteroides Ratio of Microbiota
timeFrame: Pre-travel to 14 Weeks Post-Travel
measure: Change in Enteropathogens of Stool Microbiota
timeFrame: Pre-travel to 14 Weeks Post-Travel
measure: Change in Stool Resistome
timeFrame: Pre-travel to 14 Weeks Post-Travel
Secondary outcomes:
measure: Reversion toward pre-travel microbiota state
timeFrame: Pre-travel to 14 Weeks Post-Travel
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Univeristy Hospital Midtown, TravelWell Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Colleen S Kraft, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: