Athletic PerformanceNCT07093112
Decoding Gut-Brain Biomarkers and Developing a Minimally Intrusive Gut Microbiome Sampling: Enhancing Cognitive Well-being in Athletes
A study testing Psychobiotic supplement in people with Athletic Performance and Gut Health, run by The University of Texas Health Science Center, Houston at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance, Gut Health
- What is being tested?
- Psychobiotic supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- soccer player affiliated with Criciúma Esporte Clube (CEC)'s base in Criciúma, Santa Catarina, Brazil
- agree to participate voluntarily
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Extremo Sul Catarinense (UNESC)
Criciúma, Santa Catarina, 88806-000
About this study
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
- Being tested
- Psychobiotic supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychobiotic supplementDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Psychobiotic supplement | Experimental | Not described Receives: Dietary Supplement: Psychobiotic supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Process as Assessed by the Questionario de Estresse e Recuperacao para Atletas (RESTQ-Sport) - Stress Subscale
The Questionário de Estresse e Recuperação para Atletas (RESTQ-Sport) assesses stress and recovery in athletes across 19 multidimensional scales: seven for general stress, five for general recovery, three for sports-specific stress, and four for sports-specific recovery. The RESTQ-Sport measures how well athletes recover from physical and mental stress over the previous three days and nights, providing a comprehensive understanding of their overall recovery status. The stress subscale score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score on the stress subscale indicates a worse outcome (higher stress).
Measured: baseline, 30 days, 1 year
Recovery Process as Assessed by the Questionario de Estresse e Recuperacao para Atletas (RESTQ-Sport) - Recovery Subscale
The Questionário de Estresse e Recuperação para Atletas (RESTQ-Sport) assesses stress and recovery in athletes across 19 multidimensional scales: seven for general stress, five for general recovery, three for sports-specific stress, and four for sports-specific recovery. The RESTQ-Sport measures how well athletes recover from physical and mental stress over the previous three days and nights, providing a comprehensive understanding of their overall recovery status. The recovery subscale score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score on the recovery subscale indicates a better outcome (better recovery).
Measured: baseline, 30 days, 1 year
Preparation for Injury Prevention as Assessed by the Musculoskeletal Injury Readiness Questionnaire (MIR-Q)
This questionnaire was developed for use with Brazilian athletes, particularly focusing on screening for musculoskeletal injury risks in various sports populations. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a better outcome, suggesting that the athlete is more prepared for injury prevention.
Measured: baseline, 30 days, 1 year
Overtraining as assessed by the Overtraining Questionnaire
The Overtraining Questionnaire measures overtraining syndrome in athletes, focusing on physical, psychological, social, and physiological factors, and it is designed to identify early signs of overtraining and prevent further progression of symptoms. The Brazilian adaptation will be used. The questionnaire is divided into six subscales: performance, psychological state, physiological responses, social factors, nutrition, and infection. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome, representing a higher risk or symptoms of overtraining.
Measured: baseline, 30 days, 1 year
Psychological distress as Assessed by the General Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) focusses on symptoms like excessive worry and difficulty controlling anxiety, as well as physical symptoms such as restlessness and fatigue. The GAD-7 was adapted for Brazilian Portuguese for use with the general adult population and has been validated for different age groups, including adolescents in Brazil. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome (greater anxiety).
Measured: baseline, 30 days, 1 year
Psychological distress as Assessed by the Patient Depression Questionnaire - Adolescents (PHQ-A)
The Patient Health Questionnaire-9 (PHQ-9) measures the severity of depressive symptoms in clinical and non-clinical populations. It consists of nine items that assess the frequency of depressive symptoms over the past two weeks. The PHQ-9 was adapted for Brazilian Portuguese and validated among adults in the general population in Pelotas, Brazil. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day), providing a total depression severity score. The score will be transformed into a percentage for a total score ranging from 0 to 100, and this will be reported. A higher score indicates a worse outcome (i.e., greater depressive symptoms).
Measured: baseline, 30 days, 1 year
Secondary outcomes (8)
Psychological distress as Assessed by the Athletic Coping Skills Inventory - Brazilian Portuguese version (ACSI-25BR)
The Athletic Coping Skills Inventory was developed to assess psychological coping skills in athletes. A Brazilian Portuguese version of the ACSI called the ACSI-25BR, which was adapted for Brazilian athletes, will be used. The ACSI is a multidimensional instrument, divided into seven subscales: coping with adversity, peaking under pressure, goal setting and mental preparation, concentration, freedom from worry, confidence and motivation, and coachability. The total score on these items reflects an athlete's overall coping resources. The total score will be transformed into a percentage for comparison (ranging from 0 to 100). A higher score indicates a better outcome, suggesting stronger coping skills.
Measured: baseline, 30 days, 1 year
Cognitive function as Indicated by Impulsivity as Assessed by the Delay Discounting Task (DD)
The Delay Discounting (DD) Task measures impulsivity through repeated choices between a smaller, immediately available reward and a larger, delayed reward. A Brazilian Portuguese adaptation will be used. The k value will be reported. The k value is represents an individual's discount rate and is often used as a measure of behavioral impulsivity. The k value is obtained by the formula V=A/(1+kD) ), where V is the present value of the future reward, A is the reward amount, and D is the delay associated with the reward. The k value (discount rate) typically ranges from very low (around 0.00016) to high (around 0.25). A higher discount rate (k) (which indicates choosing smaller immediate rewards) indicates a worse outcome, suggesting higher impulsivity.
Measured: baseline, 30 days, 1 year
Cognitive function as Assessed by the Barkley Deficits in Executive Functioning Scale (BDEF)
The Barkley Deficits in Executive Functioning Scale (BDEFS) assesses deficits in executive functioning in adults. It consists of 89 items that evaluate executive functioning across five domains: self-management of time, self-organization and problem-solving, self-restraint, self-motivation, and self-regulation of emotion. The BDEFS provides a comprehensive measure of the impact of executive function deficits on daily life, particularly in managing tasks, time, and emotions. The Brazilian Portuguese adaptation of the BDEFS will be used. The score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome, representing greater deficits in executive functioning.
Measured: baseline, 30 days, 1 year
Cognitive function as Assessed by the Trail Making Test (TMT)
The Trail Making Test (TMT) assesses processing speed, cognitive flexibility, attention, and visual-motor speed. The time taken to complete the task will be reported and ranges from 0 to 5 minutes. A greater time indicates a worse outcome, reflecting slower cognitive processing speed.
Measured: baseline, 30 days, 1 year
Cognitive function as Assessed by the Verbal Fluency Test (VFT)
The Verbal Fluency Test (VFT) assesses verbal memory, lexical retrieval, and cognitive flexibility, with a focus on both phonemic and semantic fluency. The test includes tasks that require participants to generate as many words as possible beginning with a specific letter (phonemic fluency) or generate as many words as possible from a given category (semantic fluency). The Brazilian Portuguese adaptation will be used. A total score will be reported, which is the number of correct words produced. A higher score indicates a better outcome, representing better verbal fluency and cognitive flexibility.
Measured: baseline, 30 days, 1 year
Cognitive function as Assessed by the Wechsler Adult Intelligence Scale®, Third Edition (WAIS-III)
The Digits subtest from the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III) consists of two parts: a forward task, where participants repeat a sequence of digits in the same order, and a backward task, where they repeat the sequence in reverse. The longest correctly repeated sequence is used to evaluate working memory capacity and cognitive load. The Brazilian Portuguese adaptation will be used. The score is based on the longest sequence of digits correctly recalled (0-14 forward and 0-12 backward). Total score will be reported and ranges from 0 to 28. A higher score indicates a better outcome, reflecting greater working memory capacity.
Measured: baseline, 30 days, 1 year
Childhood Trauma as Assessed by the Childhood Trauma Questionnaire (CTQ)
The Childhood Trauma Questionnaire evaluates five types of childhood trauma: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. Each form of trauma is scored on a Likert scale, with higher scores indicating more severe trauma. The main outcomes help The questionnaire quantifies the impact of early life stress on later health and functioning. The Brazilian Portuguese adaptation will be used. The score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome, representing more severe childhood trauma.
Measured: baseline, 30 days, 1 year
Gastrointestinal Symptoms as Assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
The Gastrointestinal Symptom Rating Scale (GSRS) assesses the frequency and severity of gastrointestinal symptoms, particularly in patients with irritable bowel syndrome and peptic ulcer disease. The GSRS consists of 15 items that assess five domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. The Brazilian Portuguese adaptation will be used. The score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome, reflecting more severe or frequent gastrointestinal symptoms.
Measured: baseline, 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start10 Mar 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Extremo Sul Catarinense (UNESC), National Football League
- Responsible party
- Principal investigator, Tatiana Barichello, The University of Texas Health Science Center, Houston
- Investigators
- Tatiana Barichello, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093112
- Sponsor's protocol ID
- HSC-MS-24-0876
- Status last verified
- Jul 2025
- First submitted
- 27 May 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding Gut-Brain Biomarkers and Developing a Minimally Intrusive Gut Microbiome Sampling: Enhancing Cognitive Well-being in Athletes
- ClinicalTrials.gov ID
- NCT07093112
- Acronym / sponsor ID
- HSC-MS-24-0876
- Conditions
- Athletic Performance, Gut Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Universidade do Extremo Sul Catarinense (UNESC), National Football League
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychobiotic supplement | Experimental | Dietary Supplement: Psychobiotic supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- soccer player affiliated with Criciúma Esporte Clube (CEC)'s base in Criciúma, Santa Catarina, Brazil
- agree to participate voluntarily
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychobiotic supplementThe 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 | Psychobiotic supplement |
| PlaceboThe 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. | Dietary supplement | Placebo |
Primary outcome
Recovery Process as Assessed by the Questionario de Estresse e Recuperacao para Atletas (RESTQ-Sport) - Stress Subscale
Time frame: baseline, 30 days, 1 year
The Questionário de Estresse e Recuperação para Atletas (RESTQ-Sport) assesses stress and recovery in athletes across 19 multidimensional scales: seven for general stress, five for general recovery, three for sports-specific stress, and four for sports-specific recovery. The RESTQ-Sport measures how well athletes recover from physical and mental stress over the previous three days and nights, providing a comprehensive understanding of their overall recovery status. The stress subscale score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score on the stress subscale indicates a worse outcome (higher stress).
Recovery Process as Assessed by the Questionario de Estresse e Recuperacao para Atletas (RESTQ-Sport) - Recovery Subscale
Time frame: baseline, 30 days, 1 year
The Questionário de Estresse e Recuperação para Atletas (RESTQ-Sport) assesses stress and recovery in athletes across 19 multidimensional scales: seven for general stress, five for general recovery, three for sports-specific stress, and four for sports-specific recovery. The RESTQ-Sport measures how well athletes recover from physical and mental stress over the previous three days and nights, providing a comprehensive understanding of their overall recovery status. The recovery subscale score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score on the recovery subscale indicates a better outcome (better recovery).
Preparation for Injury Prevention as Assessed by the Musculoskeletal Injury Readiness Questionnaire (MIR-Q)
Time frame: baseline, 30 days, 1 year
This questionnaire was developed for use with Brazilian athletes, particularly focusing on screening for musculoskeletal injury risks in various sports populations. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a better outcome, suggesting that the athlete is more prepared for injury prevention.
Overtraining as assessed by the Overtraining Questionnaire
Time frame: baseline, 30 days, 1 year
The Overtraining Questionnaire measures overtraining syndrome in athletes, focusing on physical, psychological, social, and physiological factors, and it is designed to identify early signs of overtraining and prevent further progression of symptoms. The Brazilian adaptation will be used. The questionnaire is divided into six subscales: performance, psychological state, physiological responses, social factors, nutrition, and infection. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome, representing a higher risk or symptoms of overtraining.
Psychological distress as Assessed by the General Anxiety Disorder-7 (GAD-7)
Time frame: baseline, 30 days, 1 year
The Generalized Anxiety Disorder-7 (GAD-7) focusses on symptoms like excessive worry and difficulty controlling anxiety, as well as physical symptoms such as restlessness and fatigue. The GAD-7 was adapted for Brazilian Portuguese for use with the general adult population and has been validated for different age groups, including adolescents in Brazil. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome (greater anxiety).
Psychological distress as Assessed by the Patient Depression Questionnaire - Adolescents (PHQ-A)
Time frame: baseline, 30 days, 1 year
The Patient Health Questionnaire-9 (PHQ-9) measures the severity of depressive symptoms in clinical and non-clinical populations. It consists of nine items that assess the frequency of depressive symptoms over the past two weeks. The PHQ-9 was adapted for Brazilian Portuguese and validated among adults in the general population in Pelotas, Brazil. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day), providing a total depression severity score. The score will be transformed into a percentage for a total score ranging from 0 to 100, and this will be reported. A higher score indicates a worse outcome (i.e., greater depressive symptoms).
8 secondary outcomes
Psychological distress as Assessed by the Athletic Coping Skills Inventory - Brazilian Portuguese version (ACSI-25BR)
Time frame: baseline, 30 days, 1 year
Cognitive function as Indicated by Impulsivity as Assessed by the Delay Discounting Task (DD)
Time frame: baseline, 30 days, 1 year
Cognitive function as Assessed by the Barkley Deficits in Executive Functioning Scale (BDEF)
Time frame: baseline, 30 days, 1 year
Cognitive function as Assessed by the Trail Making Test (TMT)
Time frame: baseline, 30 days, 1 year
Cognitive function as Assessed by the Verbal Fluency Test (VFT)
Time frame: baseline, 30 days, 1 year
Cognitive function as Assessed by the Wechsler Adult Intelligence Scale®, Third Edition (WAIS-III)
Time frame: baseline, 30 days, 1 year
Childhood Trauma as Assessed by the Childhood Trauma Questionnaire (CTQ)
Time frame: baseline, 30 days, 1 year
Gastrointestinal Symptoms as Assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: baseline, 30 days, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana Barichello, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychobiotic supplement in people with Athletic Performance and Gut Health, run by The University of Texas Health Science Center, Houston at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery Process as Assessed by the Questionario de Estresse e Recuperacao para Atletas (RESTQ-Sport) - Stress Subscale (time frame: baseline, 30 days, 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.