Efficacy of Probiotics for Parkinson Disease (PD)

Last updated: April 22, 2024
Sponsor: Changhua Christian Hospital
Overall Status: Trial Not Available

Phase

N/A

Condition

Dystonia

Depression

Neurologic Disorders

Treatment

Placebo

probiotics

Clinical Study ID

NCT06118294
230723
  • Ages 41-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The age between 41-80 years old and at least the elementary education level.
  • Diagnosed as a patient with Parkinson's disease of modified Hoehn and Yahr Stagebetween 1 and 3 as rated.

Exclusion

Exclusion Criteria:

  • Diagnosed before 40 years old.
  • Used probiotic products in powder, capsule, or tablet form within four weeks.
  • Have taken antibiotics within four weeks.
  • Those who are not suitable to participate in the research are judged by PI.

Study Design

Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
November 08, 2023
Estimated Completion Date:
October 30, 2026

Study 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.

Connect with a study center

  • Changhua Christian Hospital (CCH)

    Changhua, 50006
    Taiwan

    Site Not Available

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