Decoding Gut-Brain Biomarkers and Developing a Minimally Intrusive Gut Microbiome Sampling: Enhancing Cognitive Well-being in Athletes
NCT ID: NCT07093112
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
160 participants
INTERVENTIONAL
2025-03-10
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Psychobiotic supplement
Psychobiotic supplement
The psychobiotic supplement consists of Bifidobacterium lactis CCT 7858 and Lactobacillus rhamnosus CCT 7863, at a final concentration of 1 x 10\^10 CFU/g (GABBIA® Biotechnology, Santa Catarina, Brazil).
The intervention will be administered once daily for 90 days, spanning the pre-season and start-season phases with an interval and restarting for 90 days until the end-season phase.
Placebo
Placebo
The placebo consists of maltodextrin. The intervention will be administered once daily for 90 days, spanning the pre-season and start-season phases with an interval and restarting for 90 days until the end-season phase.
Interventions
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Psychobiotic supplement
The psychobiotic supplement consists of Bifidobacterium lactis CCT 7858 and Lactobacillus rhamnosus CCT 7863, at a final concentration of 1 x 10\^10 CFU/g (GABBIA® Biotechnology, Santa Catarina, Brazil).
The intervention will be administered once daily for 90 days, spanning the pre-season and start-season phases with an interval and restarting for 90 days until the end-season phase.
Placebo
The placebo consists of maltodextrin. The intervention will be administered once daily for 90 days, spanning the pre-season and start-season phases with an interval and restarting for 90 days until the end-season phase.
Eligibility Criteria
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Inclusion Criteria
* agree to participate voluntarily
Exclusion Criteria
14 Years
25 Years
ALL
Yes
Sponsors
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Universidade do Extremo Sul Catarinense (UNESC)
UNKNOWN
National Football League Players Association (NFLPA)
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Tatiana Barichello
Associate Professor
Principal Investigators
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Tatiana Barichello, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Universidade do Extremo Sul Catarinense (UNESC)
Criciúma, Santa Catarina, Brazil
Countries
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Other Identifiers
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HSC-MS-24-0876
Identifier Type: -
Identifier Source: org_study_id
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