Efficacy of Probiotics for Parkinson Disease (PD)

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06118294
Study type	Interventional
Source	Changhua Christian Hospital
Contact
Status	Withdrawn
Phase	N/A
Start date	November 8, 2023
Completion date	October 30, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.