Efficacy of Probiotics for Parkinson Disease (PD)

NCT06118294 | Withdrawn

• 1 other identifier: 230723
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease (PD); Movement Disorders; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Clinical Global Impression scales of Severity rated by clinician（CGI）

  From Baseline to 12 Weeks Assessed

• UPDRS I-IV

  From Baseline to 12 Weeks Assessed

• Q-LES-Q

  From Baseline to 12 Weeks Assessed

• Visual Analogue Scale for GI symptoms, VAS-GI

  From Baseline to 12 Weeks Assessed

• PGI-C

  From Baseline to 12 Weeks Assessed

Study Arms (2)

Probiotics

EXPERIMENTAL

daily ingestion of 2 capsules of probiotics (\>30 billion CFU/capsule)

Dietary Supplement: probiotics

Placebo

PLACEBO COMPARATOR

daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose

Dietary Supplement: Placebo

Interventions

probiotics DIETARY_SUPPLEMENT

\>30 billion CFU/capsule

Probiotics

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 41 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Changhua Christian Hospital (CCH)

Changhua, 50006, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Depression; Anxiety Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 300 Participants are assigned to the probiotics and a placebo group, under the double-blind trial.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

TW (1)