CognitionPROFILENCT07457242
Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults
A study testing Probiotic Supplementation (Lactobacillus plantarum) in people with Cognition and Multiomics, run by OneCarbon.
Trial summary
This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition, Multiomics, Microbiome Analysis
- What is being tested?
- Probiotic Supplementation (Lactobacillus plantarum)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2027to 1 Jul 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older at the time of providing informed consent.
- In generally good health, with no known medical conditions that could interfere with the aims of the study or participant safety, as judged by self-report and screening questionnaire.
- No history of significant psychiatric or neurological illness
- Ability to complete study specific tasks, including:
- Daily oral intake of a probiotic capsule
- Self-collection of stool samples
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- Completion of online questionnaires and simple cognitive tasks
- Able to read, understand, and communicate in English, in order to give informed consent and follow study instructions.
- Access to the internet and a suitable device (e.g., smartphone, tablet, or computer) for completing online aspects of the study.
Who cannot join
- Participants will be excluded from the study if any of the following criteria apply:
- Use of any systemic antibiotic or systemic immunosuppressive medication within the past 8 weeks, including but not limited to:
- β-lactam antibiotics, macrolides, tetracyclines, fluoroquinolones, aminoglycosides, glycopeptides, sulfonamides, antimycobacterial agents, systemic antifungals or antivirals
- Use of any systemic immunosuppressants within the past 16 weeks, including, but not limited to:
- Systemic corticosteroids, conventional immunosuppressants, biologic immunomodulators, targeted synthetic immunosuppressants, cytotoxic chemotherapy, or transplant-related immunosuppression.
- A longer exclusion window is applied for systemic immunosuppressive therapies due to their prolonged and potentially lasting effects on immune function and gut microbial composition compared with systemic antibiotics.
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- Participants who commence systemic antibiotics or immunosuppressive therapy after enrolment will not be withdrawn from safety monitoring but will stop the supplement and will not continue the intervention phase of the study. With participant consent, data collected may still be used.
- Major gastrointestinal disease or surgery:
- Any history of significant gastrointestinal disease or surgery that may alter gut microbiome composition, immune function, or nutrient absorption, including but not limited to inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis); coeliac disease or other chronic malabsorptive disorders; chronic liver, biliary, or pancreatic disease; moderate-to-severe or unstable irritable bowel syndrome; gastrointestinal malignancy; chronic gastrointestinal motility disorders; recurrent Clostridioides difficile infection; or any major gastrointestinal surgery such as bowel resection, bariatric surgery, colectomy, ileostomy or colostomy. Prior appendectomy or cholecystectomy alone is not exclusionary.
- Current pregnancy or development of pregnancy, breastfeeding
- Known allergy to probiotic or compounding ingredients:
- Vitamin D3
- Isomaltooligosaccharide
- Yeast extract
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months.
During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers.
This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease. Participants will be invited to participate in a follow-up visit to assess long-term effects.
- Conditions
- Cognition, Multiomics, Microbiome Analysis, Metabolome, Proteome, Metagenome
- Being tested
- Probiotic Supplementation (Lactobacillus plantarum)
- Keywords
- Probiotics, Dietary Supplements, Microbiome, Multi-omics, Metabolomics, Proteomics, Mitochondrial Function, Cellular Metabolism, Short-Chain Fatty Acids, Bioinformatics, Healthy volunteers, Pilot study, feasibility study, cognitive function, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Supplementation (Lactobacillus plantarum)Dietary supplement
This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked.
| Study group | Role | What they receive |
|---|---|---|
| Short Phase Group | Experimental | This group will receive supplementation for 1 month Receives: Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum) |
| Long Phase Group | Experimental | This group will receive supplementation for 6 months Receives: Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metagenome of stool samples
The investigators will evaluate changes in genetic material in participant stool, representing establishment of the probiotic in the digestive tract
Measured: From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
Secondary outcomes (6)
Change in blood multiome
This measure will evaluate change in blood proteins (plasma proteome) and blood metabolites (plasma metabolome). Both measures are quantified using mass to charge ratio.
Measured: From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
Changes in cognition
Participants will complete a weekly online cognitive test administered via our remote platform. This generates a score relativised to each participant's performance, and does not utilise a scale.
Measured: Assessed weekly from enrolment and to end of treatment at 4 or 24 weeks respectively.
Change in daytime sleepiness
Participants will complete the Epworth Sleepiness Scale (ESS), with a minimum score of 0, and a maximum score of 24. A higher score indicates worse daytime sleepiness.
Measured: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
Change in sleep quality
Participants will complete the Pittsburgh Sleep Quality Index (PSQI) survey. This has a minimum global score of 0, and a maximum of 21. A higher score indicates worse sleep quality.
Measured: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
Change in self-reported wellbeing and mood
Participants will fill out a questionnaire at the beginning and end of the study which will ask questions about subjective mood and wellbeing.
Measured: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
Adverse event monitoring
Participants will be expected to self-report any adverse features resulting from use of the supplement
Measured: Assessed from enrolment until end of treatment at 4 or 24 weeks respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jul 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an open-label investigation involving up to 180 adult participants. It is designed to explore the biological and psychological effects of a daily probiotic supplement containing evolved bacterial strains that naturally produce metabolites associated with normal neuronal functioning. Participants will be allocated to one of two predefined study groups (n=90) that differ only by duration of supplementation and assessment schedule: Group 1 (1 month), Group 2 (6 months). Allocation is non-random and determined by study capacity and feasibility considerations. All groups receive the same probiotic intervention and complete the same types of assessments, with frequency proportional to study duration. There will be no difference in dose between groups.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OneCarbon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457242
- Sponsor's protocol ID
- PROFILE
- Acronym
- PROFILE
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personal data collected during the study will be pseudonymised at the earliest possible stage. Each participant will be assigned a unique study ID number, which will be used on all samples, questionnaires, and datasets. A separate, password-protected file will securely store the link between participant names and study IDs. This file will be accessible only to authorised study personnel. No identifiable personal information will be included in the research database or shared with external analysts. All electronic data will be stored on secure, encrypted servers in compliance with UK GDPR and the Data Protection Act 2018. Access will be limited to members of the research team through password-protected accounts and role-based permissions. Hard copies of personal data will not be collected or stored. Any correspondence containing identifiable information (e.g. email addresses) will be deleted or anonymised once no longer needed.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults
- ClinicalTrials.gov ID
- NCT07457242
- Acronym / sponsor ID
- PROFILE / PROFILE
- Conditions
- Cognition, Multiomics, Microbiome Analysis, Metabolome, Proteome, Metagenome
- Keywords
- Probiotics, Dietary Supplements, Microbiome, Multi-omics, Metabolomics, Proteomics, Mitochondrial Function, Cellular Metabolism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- OneCarbonIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 9 Mar 2026 (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.
This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months.
During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers.
This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease. Participants will be invited to participate in a follow-up visit to assess long-term effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open-label investigation involving up to 180 adult participants. It is designed to explore the biological and psychological effects of a daily probiotic supplement containing evolved bacterial strains that naturally produce metabolites associated with normal neuronal functioning. Participants will be allocated to one of two predefined study groups (n=90) that differ only by duration of supplementation and assessment schedule: Group 1 (1 month), Group 2 (6 months). Allocation is non-random and determined by study capacity and feasibility considerations. All groups receive the same probiotic intervention and complete the same types of assessments, with frequency proportional to study duration. There will be no difference in dose between groups.
| Arm | Type | Receives |
|---|---|---|
| Short Phase Group | Experimental | Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum)This group will receive supplementation for 1 month |
| Long Phase Group | Experimental | Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum)This group will receive supplementation for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years or older at the time of providing informed consent.
- In generally good health, with no known medical conditions that could interfere with the aims of the study or participant safety, as judged by self-report and screening questionnaire.
- No history of significant psychiatric or neurological illness
- Ability to complete study specific tasks, including:
- Daily oral intake of a probiotic capsule
Key exclusion criteria (14 listed)
- Participants will be excluded from the study if any of the following criteria apply:
- Use of any systemic antibiotic or systemic immunosuppressive medication within the past 8 weeks, including but not limited to:
- β-lactam antibiotics, macrolides, tetracyclines, fluoroquinolones, aminoglycosides, glycopeptides, sulfonamides, antimycobacterial agents, systemic antifungals or antivirals
- Use of any systemic immunosuppressants within the past 16 weeks, including, but not limited to:
- Systemic corticosteroids, conventional immunosuppressants, biologic immunomodulators, targeted synthetic immunosuppressants, cytotoxic chemotherapy, or transplant-related immunosuppression.
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 |
|---|---|---|
| Probiotic Supplementation (Lactobacillus plantarum)This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked. | Dietary supplement | Long Phase Group, Short Phase Group |
Primary outcome
Changes in metagenome of stool samples
Time frame: From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
The investigators will evaluate changes in genetic material in participant stool, representing establishment of the probiotic in the digestive tract
6 secondary outcomes
Change in blood multiome
Time frame: From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
Changes in cognition
Time frame: Assessed weekly from enrolment and to end of treatment at 4 or 24 weeks respectively.
Change in daytime sleepiness
Time frame: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
Change in sleep quality
Time frame: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
Change in self-reported wellbeing and mood
Time frame: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
Adverse event monitoring
Time frame: Assessed from enrolment until end of treatment at 4 or 24 weeks respectively.
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 21 Sep 2026.
- Individual participant dataSharing planned: No. All personal data collected during the study will be pseudonymised at the earliest possible stage. Each participant will be assigned a unique study ID number, which will be used on all samples, questionnaires, and datasets. A separate, password-protected file will securely store the link between participant names and study IDs. This file will be accessible only to authorised study personnel. No identifiable personal information will be included in the research database or shared with external analysts. All electronic data will be stored on secure, encrypted servers in compliance with UK GDPR and the Data Protection Act 2018. Access will be limited to members of the research team through password-protected accounts and role-based permissions. Hard copies of personal data will not be collected or stored. Any correspondence containing identifiable information (e.g. email addresses) will be deleted or anonymised once no longer needed.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Supplementation (Lactobacillus plantarum) in people with Cognition and Multiomics, run by OneCarbon.
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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Research Team (+44 7757 056785, team@healthspanbiotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in metagenome of stool samples (time frame: From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.). 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 21 Sep 2026.