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Early Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults (ePROFILE20)

6. Oktober 2026 aktualisiert von: OneCarbon

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Participants self-administer one capsule of 1C-01 daily for 28 days. 1C-01 is a live-culture food supplement.

Biological sampling occurs at two timepoints, baseline and end of intervention. Blood and stool is self-collected by the participant using a supplied kit and transported by study staff. Stool undergoes shotgun metagenomic sequencing; plasma undergoes untargeted metabolomic and proteomic profiling. Samples are rendered acellular on receipt and held at the sponsor's primary site.

Remote assessments are delivered through a browser-based study application and are completed together in a single session at baseline and at scheduled fortnightly intervals thereafter. Each session comprises the seven-task cognitive battery, the sleep questionnaire, the mood and stress ratings, and the adherence record for the preceding interval. The cognitive battery is modelled on the UK Biobank assessments using original task content; trial-level response data are retained alongside summary scores. The exit questionnaire is presented once, at the end of the intervention period.

The study is conducted in a hybrid format, with remote assessment and in-person sample collection at participants' homes.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigtes Königreich
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Vereinigtes Königreich, CB2 0AW
        • OneCarbon
        • Kontakt:
        • Hauptermittler:
          • Claudia Mitrofan, MChem, MRes, PhD, MB BChir

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention Group

4 week course of 1C-01
Nahrungsergänzungsmittel: Probiotic Supplement (1C-01)

Proprietary probiotic supplement

Andere Namen:
  • HSB001
  • 1C-01

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stool metagenome
Zeitfenster: From enrolment to end of treatment at 4 weeks

Change from baseline in stool metagenomic markers, representing stool microbiome.
From enrolment to end of treatment at 4 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Plasma Metabolome, Proteome
Zeitfenster: From enrolment to end of treatment at 4 weeks

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.
From enrolment to end of treatment at 4 weeks
Cognitive Task Performance
Zeitfenster: From enrolment to end of treatment at 4 weeks.

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.
From enrolment to end of treatment at 4 weeks.
Self-reported Sleep
Zeitfenster: From enrolment to end of treatment at 4 weeks.

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.
From enrolment to end of treatment at 4 weeks.
Wellbeing
Zeitfenster: Enrolment to end of treatment at 4 weeks.

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.
Enrolment to end of treatment at 4 weeks.
Adherence
Zeitfenster: Enrolment to end of treatment at 4 weeks.

Self-reported number of days on which the study supplement was taken during each consecutive 14-day period, recorded by participants at the end of each period. Integer count from 0 to 14 per period; higher indicates greater adherence. Reported as the count per period and as percentage adherence (days taken divided by 14, multiplied by 100).
Enrolment to end of treatment at 4 weeks.
Adverse Events
Zeitfenster: Enrolment to end of treatment at 4 weeks.

Count of adverse events reported by participants, and the severity of each event graded as mild, moderate or severe. Reported as the number of participants with at least one adverse event, the total number of events, and the number of events at each severity grade. Higher counts indicate a less favourable tolerability profile.
Enrolment to end of treatment at 4 weeks.
Acceptability of study procedures
Zeitfenster: Assessed at week 4 (end of treatment)

Participant-rated acceptability of five study procedures, assessed once at the Week 4 end-of-intervention visit using a study-specific questionnaire. Each procedure is rated on a 5-point ordinal scale: 1 = not at all acceptable, 2 = slightly acceptable, 3 = moderately acceptable, 4 = very acceptable, 5 = completely acceptable. Higher scores indicate greater acceptability. Each item is reported separately; no total or composite score is derived. Three optional free-text questions are collected and reported descriptively. Feasibility is additionally assessed as recruitment rate (participants enrolled as a proportion of those screened, and mean enrolled per month across recruitment) and outcome completion (proportion of scheduled assessments and biological samples completed and usable, reported separately for stool samples, blood samples, cognitive batteries, and mood and stress ratings).
Assessed at week 4 (end of treatment)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

OneCarbon

Ermittler

  • Studienleiter: Benjamin R Underwood, MA MBBS PhD FRCPsych CertMedEd, Cambridgeshire and Peterborough NHS Foundation Trust

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. September 2027

Studienanmeldedaten

Zuerst eingereicht

19. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. September 2026

Zuerst gepostet (Tatsächlich)

25. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ePROFILE20

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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