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

NCT07841457 | Not Yet Recruiting

• 1 other identifier: ePROFILE20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pre-post, open-label pilot feasibility 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 1 month. 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.

Conditions

Probiotic Intervention; Healthy Adult Participants

Keywords

probiotic; metabolomic; metagenomic

Outcome Measures

Primary Outcomes (1)

• Stool metagenome

  Change from baseline in stool metagenomic markers, representing stool microbiome.

  From enrolment to end of treatment at 4 weeks

Secondary Outcomes (7)

• Plasma Metabolome, Proteome

  From enrolment to end of treatment at 4 weeks

• Cognitive Task Performance

  From enrolment to end of treatment at 4 weeks.

• Self-reported Sleep

  From enrolment to end of treatment at 4 weeks.

• Wellbeing

  Enrolment to end of treatment at 4 weeks.

• Adherence

  Enrolment to end of treatment at 4 weeks.

Study Arms (1)

Intervention Group

EXPERIMENTAL

4 week course of 1C-01

Dietary Supplement: Probiotic Supplement (1C-01)

Interventions

Probiotic Supplement (1C-01) DIETARY_SUPPLEMENT

Proprietary probiotic supplement

Also known as: HSB001, 1C-01

Intervention Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50 years or older at the time of providing informed consent.
• Stable medical conditions are permitted provided they are not psychiatric or neurological in nature and are not known to interfere with the aims of the study, participant safety, or patient ability to consent.
• 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:

• Previous use of the study probiotic (1C-01) as individuals who have previously taken 1C-01 are not eligible.
• 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:
• Women of child-bearing potential (WOCBP). Women of non-child-bearing potential (WONCBP) are eligible; for the purposes of this study, WONCBP is defined as post-menopausal, i.e. no menstrual period for ≥12 consecutive months with no alternative medical cause. Breastfeeding women are also excluded.
• Known allergy to probiotic or compounding ingredients:
• Vitamin D3
• Isomaltooligosaccharide
• Yeast extract

Sponsors & Collaborators

• OneCarbon: lead

Study Sites (1)

OneCarbon

Cambridge, Cambridgeshire, CB2 0AW, United Kingdom

Location

Related Links

• Related Info

Study Officials

• Benjamin R Underwood, MA MBBS PhD FRCPsych CertMedEd

  Cambridgeshire and Peterborough NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Yizhou Yu, PhD

CONTACT

+44 7757 056785; yizhou@onecarbon.com

Suleyman Noordeen, MB BChir

CONTACT

+447985926284; suleyman@onecarbon.com

Study Design

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

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)