Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487975
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-27
Brief Title:
Bacillus Subtilis in Parkinsons Disease
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Effects of Bacillus Subtilis on Blood and Gut Biomarkers in Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mechanisms of action as well as being acceptable as a regular supplement for people with Parkinsons 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 11 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 faecalblood 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None