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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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 Summary:

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
Sponsor: Emory University

Current Primary Outcome:

  • Change in Predominant Intestinal Microbiota Genus or Strain [ Time Frame: Pre-travel to 14 Weeks Post-Travel ]
    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.
  • Change in Alpha and Beta Diversity of Intestinal Microbiota [ Time Frame: Pre-travel to 14 Weeks Post-Travel ]
    Maximum percentage of all genes identified included within the same taxon will be determined from each stool sample.
  • Change in Firmicutes:Bacteroides Ratio of Microbiota [ Time Frame: Pre-travel to 14 Weeks Post-Travel ]
    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.
  • Change in Enteropathogens of Stool Microbiota [ Time Frame: Pre-travel to 14 Weeks Post-Travel ]
    The presence of enteropathogens in stool samples will be examined pre- and post-travel.
  • Change in Stool Resistome [ Time Frame: Pre-travel to 14 Weeks Post-Travel ]
    Review of the resistome will include a summary of the overall number and diversity of bacterial and fungal resistance genes including any new acquisition.


Original Primary Outcome: Same as current

Current Secondary Outcome: Reversion toward pre-travel microbiota state [ Time Frame: Pre-travel to 14 Weeks Post-Travel ]

Microbiota profile changes and reversion to or toward the pre-travel state will be assessed by comparing pre-travel stool specimen sequencing results to short-term post-travel and long-term post-travel stool specimen sequencing results.


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: February 2, 2017
Date Started: June 1, 2017
Date Completion: February 28, 2019
Last Updated: April 27, 2017
Last Verified: April 2017