Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults

NCT07457242 | Not Yet Recruiting

• 1 other identifier: PROFILE
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognition; Multiomics; Microbiome Analysis; Metabolome; Proteome; Metagenome; Probiotics Supplement; Gut-brain Axis; Pilot Study; Adult; Sleep

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

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  Assessed weekly from enrolment and to end of treatment at 4 or 24 weeks respectively.

• Change in daytime sleepiness

  Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.

• Change in sleep quality

  Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.

• Change in self-reported wellbeing and mood

  Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.

Study Arms (2)

Short Phase Group

EXPERIMENTAL

This group will receive supplementation for 1 month

Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum)

Long Phase Group

EXPERIMENTAL

This group will receive supplementation for 6 months

Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum)

Interventions

Probiotic Supplementation (Lactobacillus plantarum) DIETARY_SUPPLEMENT

This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked.

Long Phase Group; Short Phase Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:
• Current pregnancy or development of pregnancy, breastfeeding
• Known allergy to probiotic or compounding ingredients:
• Vitamin D3
• Isomaltooligosaccharide
• Yeast extract

Sponsors & Collaborators

• Healthspan Biotics: lead

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Research Team

CONTACT

+44 7757 056785; team@healthspanbiotics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share