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

CompletedOBSERVATIONAL
Enrollment

10

Participants

Timeline

Start Date

November 7, 2017

Primary Completion Date

December 1, 2018

Study Completion Date

December 1, 2018

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."

Trial Locations (2)

30308

Emory Univeristy Hospital Midtown, TravelWell Center, Atlanta

30322

Emory University, Atlanta

All Listed Sponsors
collaborator

Centers for Disease Control and Prevention

FED

lead

Emory University

OTHER

NCT03043300 - A Pilot Study Assessing Intestinal Microbiota Diversification and Changes After Travel to South(East) Asia From the US | Biotech Hunter | Biotech Hunter