Clinical trial NCT06118294: Efficacy of Probiotics for Parkinson Disease (PD)
Official title: Efficacy of Probiotics for Parkinson Disease (PD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson's Disease (PD)
Movement Disorders
Depression
Anxiety
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2023-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 41
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 300 Participants are assigned to the probiotics and a placebo group, under the double-blind trial.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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 Stage between 1 and 3 as rated.

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.

Primary outcomes:
measure: UPDRS III
timeFrame: From Baseline to 12 Weeks Assessed
Secondary outcomes:
measure: Clinical Global Impression scales of Severity rated by clinician（CGI）
timeFrame: From Baseline to 12 Weeks Assessed
measure: UPDRS I-IV
timeFrame: From Baseline to 12 Weeks Assessed
measure: Q-LES-Q
timeFrame: From Baseline to 12 Weeks Assessed
measure: Visual Analogue Scale for GI symptoms, VAS-GI
timeFrame: From Baseline to 12 Weeks Assessed
measure: PGI-C
timeFrame: From Baseline to 12 Weeks Assessed
measure: PHQ-9
timeFrame: From Baseline to 12 Weeks Assessed
measure: Differences in the State and Trait Anxiety Index (STAI)
timeFrame: From Baseline to 12 Weeks Assessed
measure: Difference in Oxidative stress - blood level of HSCRP
timeFrame: From Baseline to 12 Weeks Assessed
measure: Gut microbiota
timeFrame: From Baseline to 12 Weeks Assessed
measure: Level of Growth Differentiation Factor-15
timeFrame: From Baseline to 12 Weeks Assessed
measure: brain-derived neurotropic factor (BDNF)
timeFrame: From Baseline to 12 Weeks Assessed
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital (CCH)
Study officials:
References: