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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Athletic Performance Gut Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Psychobiotic supplement

Group Type EXPERIMENTAL

Psychobiotic supplement

Intervention Type DIETARY_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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* soccer player affiliated with Criciúma Esporte Clube (CEC)'s base in Criciúma, Santa Catarina, Brazil
* agree to participate voluntarily

Exclusion Criteria

* athletes who withdraw from the study, cannot collect biological samples or answer the questionnaires during the pre-established times, and fail to take the capsules recommended in the study
Minimum Eligible Age

14 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade do Extremo Sul Catarinense (UNESC)

UNKNOWN

Sponsor Role collaborator

National Football League Players Association (NFLPA)

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Tatiana Barichello

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Brazil

Other Identifiers

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HSC-MS-24-0876

Identifier Type: -

Identifier Source: org_study_id

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