Early Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorOneCarbon
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Daily oral intake of a probiotic capsule
Disqualifiers
Previous use of the study probiotic (1C-01) as individuals who have previously taken 1C-01 are not eligible.
β-lactam antibiotics, macrolides, tetracyclines, fluoroquinolones, aminoglycosides, glycopeptides, sulfonamides, antimycobacterial agents, systemic antifungals or antivirals
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.
Trial design
Design model
Single group
Treatments tested in this trial
Probiotic Supplement (1C-01)
Dietary supplementProprietary probiotic supplement
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Stool metagenome
Change from baseline in stool metagenomic markers, representing stool microbiome.
Time frame
From enrolment to end of treatment at 4 weeksSecondary outcomes
1
Plasma Metabolome, Proteome
Change from baseline in plasma metabolomic and proteomic markers, representing cellular metabolism and circulating protein levels. Reported as change in normalised relative abundance for each analyte. Continuous measure.
Time frame
From enrolment to end of treatment at 4 weeks2
Cognitive Task Performance
Self-administered web-based battery of seven tasks modelled on the UK Biobank cognitive assessments. Components and scoring: reaction time (mean response latency in milliseconds across matching trials; lower is better); numeric memory (longest digit span correctly recalled; higher is better); symbol-digit matching (number of correct substitutions in 60 seconds; higher is better); word-pair memory (number of pairs correctly recalled out of 6; higher is better); matrix reasoning (number of puzzles solved correctly out of 5; higher is better); Trail Making A and Trail Making B (time to complete the sequence in milliseconds; lower is better). Each component is reported independently.
Time frame
From enrolment to end of treatment at 4 weeks.3
Self-reported Sleep
Change from baseline on a study-specific sleep questionnaire covering six domains. Sleep duration: hours of sleep per 24 hours including naps, 0 to 16 in half-hour steps; higher indicates longer sleep. Sleep quality: 5-point ordinal scale (very poor, poor, average, good, very good); higher is better. Daytime sleepiness: 4-point ordinal scale (never, sometimes, often, always); higher is worse. Difficulty falling asleep and difficulty staying asleep, each a 4-point ordinal scale (no, occasionally, yes often, every night); higher is worse. Sleep-onset latency: 4 ordered categories (under 15 minutes, 15 to 30 minutes, 30 to 60 minutes, over 60 minutes); longer is worse. Causes of night-time waking: multi-select checklist of 8 options, reported descriptively as the proportion of participants endorsing each cause, not scored. Each domain is reported separately; no total score is used as an outcome measure.
Time frame
From enrolment to end of treatment at 4 weeks.4
Wellbeing
Change from baseline in self-reported wellbeing, assessed by two single-item ratings collected at each study assessment. Mood: "How are you feeling today?", 5-point ordinal scale (very low, low, neutral, good, very good); higher is better. Stress: "Stress level today", 4-point ordinal scale (none, mild, moderate, high); higher is worse. Each item is analysed and reported separately; no composite score is derived.
Time frame
Enrolment to end of treatment at 4 weeks. Source ClinicalTrials.gov
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