Adult, Cognition, Gut-brain Axis, Metabolome, Metagenome, Microbiome Analysis, Multiomics, Pilot Study, Probiotics Supplement, Proteome, Sleep
Conditions
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
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTProbiotic Supplementation (Lactobacillus plantarum)
This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked.
Sponsors
Healthspan Biotics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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.
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in metagenome of stool samples | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood multiome | 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. | This measure will evaluate change in blood proteins (plasma proteome) and blood metabolites (plasma metabolome). Both measures are quantified using mass to charge ratio. |
| Changes in cognition | Assessed weekly from enrolment and to end of treatment at 4 or 24 weeks respectively. | 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. |
| Change in daytime sleepiness | Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively. | 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. |
| Change in sleep quality | Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively. | 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. |
| Change in self-reported wellbeing and mood | Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively. | Participants will fill out a questionnaire at the beginning and end of the study which will ask questions about subjective mood and wellbeing. |
| Adverse event monitoring | Assessed from enrolment until end of treatment at 4 or 24 weeks respectively. | Participants will be expected to self-report any adverse features resulting from use of the supplement |
Contacts
CONTACTResearch Team
Outcome results
None listed