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Decoding Gut-Brain Biomarkers and Developing a Minimally Intrusive Gut Microbiome Sampling: Enhancing Cognitive Well-being in Athletes

NCT07093112 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-30

No results posted yet for this study

Summary

The objective of this study is to assess the impact of a psychobiotic supplement on the gut health, neurological markers, and behavior of younger soccer players over the soccer season.

Conditions

  • Athletic Performance
  • Gut Health

Interventions

DIETARY_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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Universidade do Extremo Sul Catarinense (UNESC)

    collaborator UNKNOWN

  • National Football League Players Association (NFLPA)

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Tatiana Barichello, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093112 on ClinicalTrials.gov