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

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.

Conditions

• Dysbiosis

Interventions

OTHER

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.

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.

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.

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.

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.

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.

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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• Emory University

  lead OTHER

Principal Investigators

• Colleen S Kraft, MD, MSc · Emory University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-07

Primary Completion

2018-12-01

Completion

2018-12-01

Countries

• United States

Study Locations