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Stool Microbiome, Pathogens, and Infectious Agents Among Olympic and Elite Athletes (TRMC-Bio)

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ClinicalTrials.gov Identifier: NCT02818413
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Thorne Research Inc.
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic

Tracking Information
First Submitted Date June 28, 2016
First Posted Date June 29, 2016
Last Update Posted Date August 29, 2017
Actual Study Start Date June 3, 2016
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2016)
Baseline identification of microbial community present in stool [ Time Frame: Approximately 1 week after collection of stool sample ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stool Microbiome, Pathogens, and Infectious Agents Among Olympic and Elite Athletes
Official Title TRMC-Bio "Molecular Profiling of Gut Microbiome, Microbiome Metabolome, Serum Chemistry, and Metabolism-Associated SNPs in Elite Athletes"
Brief Summary This research is being done to investigate fecal microbiome and metabolome as well as serum analytes and single nucleotide polymorphisms in Olympic athletes in comparison with other elite athletes.
Detailed Description

Olympic athletes, non-Olympic elite athletes, and other active adults may have genetic and metabolic profiles that are unique. These profiles may contribute to the caliber of their athletic performance, and they may provide keys to understanding select genetic and metabolic conditions.

Therefore, the specific aims of this project are as follows:

  • Specific Aim 1: Characterize the fecal microbial communities in athletes participating in the summer 2016 games and in athletes not participating in the Olympic games
  • Specific Aim 2: Characterize the fecal microbiome metabolome (untargeted) in athletes participating in the summer 2016 games and in athletes not participating in the Olympic games
  • Specific Aim 3: Characterize selected serum analytes and single nucleotide polymorphisms (SNPs) of elite athletes participating in the Summer 2016 games and in athletes not participating in the Olympic games, via serum and saliva analyses, respectively
  • Specific Aim 4: Retain specimens from Olympic athletes participating in the summer 2016 games and in athletes not participating in the Olympic games for future research
  • Specific Aim 7: Examine for the presence of Zika virus RNA in study participants who exhibit symptoms

Stool, urine, and blood specimens will be collected to study the stool metabolome, as well as serum analytes and single nucleotide polymorphisms, and the nature and extent of exposure to pathogens and infectious agents. These will be compared between Olympic athletes and other non-Olympic elite athletes.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Stool samples will be retained for future research
Sampling Method Non-Probability Sample
Study Population Members of the U.S. Olympic teams and other elite athletes
Condition Athletic Performance
Intervention Other: Biospecimen collection and questionnaires
Biospecimen collection and questionnaires
Study Groups/Cohorts U.S. Olympic Team and elite athletes
Biospecimens will be collected from and questionnaires will be administered to U.S. Olympic team members and other elite athletes
Intervention: Other: Biospecimen collection and questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 28, 2017)
32
Original Estimated Enrollment
 (submitted: June 28, 2016)
150
Actual Study Completion Date March 21, 2017
Actual Primary Completion Date March 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Member of the Summer 2016 U.S. Olympic team and/or other elite athlete
  • English speaking
  • Willing to provide informed consent and biospecimens
  • Willing to complete questionnaires regarding normal bowel habits and general health

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02818413
Other Study ID Numbers 16-001515
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Brent A. Bauer, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Thorne Research Inc.
Investigators
Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2017