NCT06487975

Brief Summary

The aim of this study is to evaluate whether the administration of Bacillus Subtilis influences gut and blood biomarkers relevant to the proposed mechanism(s) of action, as well as being acceptable as a regular supplement for people with Parkinson's disease.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started May 2023

Typical duration for not_applicable parkinson-disease

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

March 27, 2024

Last Update Submit

April 2, 2026

Conditions

Parkinson Disease

Keywords

probioticmicrobiome

Outcome Measures

Primary Outcomes (9)

  • To assess the effect of Bacillus Subtilis on gut microbiome

    Changes in presence and abundance of Bacillus Subtilis and other bacteria in faeces following probiotic administration versus placebo. Non-parametric tests (such as Wilcoxon signed-rank test and permutational multivariate analysis of variance) will be used for alpha and beta diversity analyses, and to identify genera that have significantly changed in abundance.

    24 weeks

  • To assess the effects of Bacillus Subtilis on blood biomarkers (sphingolipid profile)

    Changes in sphingolipids following Bacillus Subtilis administration versus placebo measured using liquid chromatography-mass spectrometry

    24 weeks

  • To assess the effects of Bacillus Subtilis on blood biomarkers (pro-inflammatory cytokines)

    Changes in pro-inflammatory cytokines following Bacillus Subtilis administration versus placebo measured using V-PLEX Proinflammatory Panel 1 Human Kit

    24 weeks

  • To assess the effects of Bacillus Subtilis on blood biomarkers (neurofilament light chain)

    Changes in neurofilament light chain following Bacillus Subtilis administration versus placebo measured using Single Molecule Array assay

    24 weeks

  • To assess the effects of Bacillus Subtilis on blood biomarkers (alpha-synuclein species)

    Changes in alpha synuclein species following Bacillus Subtilis administration versus placebo measured using α-syn real-time quaking-induced conversion assays

    24 weeks

  • To assess the effects of Bacillus Subtilis on blood biomarkers (lipid profile)

    Changes in cholesterols/triglycerides following Bacillus Subtilis administration versus placebo

    24 weeks

  • To assess the effects of Bacillus Subtilis on blood biomarkers (fasting glucose)

    Changes in fasting glucose following Bacillus Subtilis administration versus placebo

    24 weeks

  • To assess the effects of Bacillus Subtilis on blood biomarkers (haemoglobin A1C)

    Changes in haemoglobin A1C following Bacillus Subtilis administration versus placebo

    24 weeks

  • To evaluate the acceptability of Bacillus Subtilis administration in PD patients

    Descriptive analysis of custom-designed Acceptability Questionnaire which includes four questions on number of missed doses, ease of swallowing, daily dosing schedule, and any other barriers to tablet compliance.

    24 weeks

Secondary Outcomes (1)

  • To evaluate the correlation between changes in gut and blood biomarkers following B. subtilis administration and motor/non-motor symptoms

    24 weeks

Study Arms (2)

Bacillus Subtilis

EXPERIMENTAL

Bacillus Subtilis 1 capsule once daily in the morning (consisting of 10x10\^9 Colony Forming Units)

Dietary Supplement: Bacillus Subtilis

Placebo

PLACEBO COMPARATOR

1 visually identical placebo capsule once daily in the morning using the same carrier (microcrystalline cellulose) as the active (but not containing Bacillus Subtilis)

Other: Placebo

Interventions

Bacillus SubtilisDIETARY_SUPPLEMENT

Bacillus Subtilis 1 capsule once daily in the morning (consisting of 10x10\^9 Colony Forming Units)

Bacillus Subtilis
PlaceboOTHER

1 visually identical placebo capsule once daily in the morning using the same carrier (microcrystalline cellulose) as the active (but not containing Bacillus Subtilis)

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson's disease
  • Able to provide written informed consent
  • Over 50 years old
  • Motor symptom duration over 12 months
  • Stable dopaminergic medication regime for at least 3 months

You may not qualify if:

  • Use of probiotic supplements and probiotic-fortified foods (such as probiotic drinks and yoghurts) within past 3 months
  • Use of antibiotics within past 3 months
  • Previous gastrointestinal surgery or chronic organic bowel disorder
  • History of clinically significant motor fluctuations
  • History of postural instability or falls
  • Current smoker
  • Known or suspected allergy to probiotics
  • Regular use of antacids, proton pump inhibitors, laxatives or anti-diarrheal drugs
  • Use of hypoglycaemic or diabetes drugs
  • Participation in clinical trial of investigational medicinal product within past 3 months
  • Co-morbidities or other factors that, in the opinion of the investigator, make the patient unlikely to comply with study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Norwegian Centre for Movement Disorders, Stavanger University Hospital

Stavanger, Norway

Location

NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • David P Breen, MBChB

    NHS Lothian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

July 5, 2024

Study Start

May 2, 2023

Primary Completion

March 5, 2025

Study Completion

November 20, 2025

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)NO(1)