Bacillus Subtilis in Parkinson's Disease

NCT ID: NCT06487975

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2025-12-31

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.

Detailed Description

Following informed consent, participants will undergo screening. If eligible, they will be invited to attend a baseline visit (week 0) to complete clinical assessments and provide a faecal and blood sample before starting their assigned intervention. Each participant will be randomised 1:1 to visually identical capsules containing either Bacillus Subtilis or placebo to be taken for 24 weeks. Telephone follow-up will be performed at week 8 to ensure compliance and answer any participant questions. Repeat clinical assessments and faecal/blood sample collection will take place at weeks 24 (treatment end date) and 36 (to assess longevity of biomarker changes after the intervention has stopped). Faecal samples will be collected at home within seven days prior to the clinic visits and brought to the appointment. Microbiota composition in faecal samples and blood biomarkers will be analysed in participant samples. Motor and non-motor symptom rating scales will also be administered.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Bacillus Subtilis

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

Group Type: EXPERIMENTAL

Bacillus Subtilis

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Bacillus Subtilis

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

ADM Protexin

INDUSTRY

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David P Breen, MBChB

Role: STUDY_CHAIR

NHS Lothian

Locations

Norwegian Centre for Movement Disorders, Stavanger University Hospital

Stavanger, , Norway

NHS Lothian

Edinburgh, , United Kingdom

Countries

Norway; United Kingdom

Other Identifiers

22/WS/0100

Identifier Type: -

Identifier Source: org_study_id