Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT06118294
Status:
WITHDRAWN
Last Update Posted:
2024-04-23
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Probiotics for Parkinson Disease (PD)
Sponsor:
Changhua Christian Hospital
Organization:
Study Overview
Official Title:
Efficacy of Probiotics for Parkinson Disease (PD)
Status:
WITHDRAWN
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI has retired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In previous clinical studies, PS128 has been reported to ameliorate motor deficits in Parkinson's disease (PD). PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
Detailed Description:
The gut microbiota plays important roles in gastrointestinal homeostasis, essential physiological processes and CNS function, and affects the gut-brain axis via neural, immune and endocrine pathways giving rise to the microbiota-gut-brain-axis (MGBA). Combining the MGBA concept and the theory that Parkinson's disease (PD) is derived in the gut, researchers have studied the relationship between the gut microbiota and the PD neurodegenerative process. Probiotics are live microorganisms that confer health benefits on the host and can improve host physical and mental health by affecting MGBA homeostasis. Lactobacillus plantarum PS128 (PS128) and Lactobacillus paracasei PS23 (PS23) are specific probiotics, known as a psychobiotic, which has been demonstrated to alleviate depression- and anxiety-like behaviors in mouse model. Furthermore, PS128 alleviated motor deficits, nigrostriatal dopaminergic neuronal cell death, and striatal dopamine reduction in the MPTP mouse model of Parkinson's disease. In previous clinical studies, PS128 has been reported to ameliorate motor deficits in PD. PS23 has been reported to delay some age-related disorders.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
The eligible participants will be administered with probiotics capsules for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment. Blood and stool samples will be collected before and after the intervention for biochemical parameters.
On the basis of previous animal and clinical studies which hope that this study can support the theory of the gut-brain axis, and have the opportunity to realize the relationship between peripheral inflammation and neurodegeneration.
The eligible participants will be administered with probiotics capsules for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment. Blood and stool samples will be collected before and after the intervention for biochemical parameters.
Study Oversight
Has Oversight DMC:
False
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?: