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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
180
This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked.
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
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.
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Assessed from enrolment until end of treatment at 4 or 24 weeks respectively.
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