Efficacy of Probiotics for Parkinson Disease (PD)

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Movement Disorders; Anxiety; Parkinson's Disease (PD)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: probiotics

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheylin Wu, Doctor; Phone Number: +886-4-7238595; Email: 14132@cch.org.tw

Study Locations

• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital (CCH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; daily ingestion of 2 capsules of probiotics (>30 billion CFU/capsule)	Dietary supplement: probiotics; >30 billion CFU/capsule
Placebo Comparator: Placebo; daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UPDRS III	The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The PART III is Motor sections.	From Baseline to 12 Weeks Assessed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PGI-C	The PGIC is a scale participants use to rate the level of change they have experienced following treatment. The PGIC is a 7-point scale from 1 (very much better) to 7 (very much worse).	From Baseline to 12 Weeks Assessed
Clinical Global Impression scales of Severity rated by clinician（CGI）	The CGIC is a single-item questionnaire that asks the investigator to assess a patient's PD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit.	From Baseline to 12 Weeks Assessed
UPDRS I-IV	The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.Scale UPDRS the sum of parts I, II and III ranges from 0 to 176. The UPDRS score has three components, each consisting of questions with 0-4 point scale. Part I assesses mentation, behavior, and mood; Part II assesses activities of daily; and Part III assesses motor abilities. Where 0 represents the absence of impairment and 4 represents the highest degree of impairment.	From Baseline to 12 Weeks Assessed
Q-LES-Q	Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).	From Baseline to 12 Weeks Assessed
Visual Analogue Scale for GI symptoms, VAS-GI	Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in patients after taking probiotics	From Baseline to 12 Weeks Assessed
PHQ-9	Measure for Major Depressive Disorder from questionnaire responses, to measure the prevalence of clinically significant depression defined as a PHQ-9 score of equal to or greater than 10.	From Baseline to 12 Weeks Assessed
Differences in the State and Trait Anxiety Index (STAI)	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.	From Baseline to 12 Weeks Assessed
Difference in Oxidative stress - blood level of HSCRP	To assess inflammation indicators, used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis	From Baseline to 12 Weeks Assessed
Gut microbiota	Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota in Stool samples before and after probiotics	From Baseline to 12 Weeks Assessed
Level of Growth Differentiation Factor-15	Level of Growth Differentiation Factor-15	From Baseline to 12 Weeks Assessed
brain-derived neurotropic factor (BDNF)	Measurement BDNF level in serum	From Baseline to 12 Weeks Assessed

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Collaborators: Bened Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 8, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Movement Disorders
• Other Study ID Numbers: 230723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No