Parkinson's disease, a chronic neurodegenerative disorder, characterized by bradykinesia, resting tremor, muscle rigidity, hyposmia, rapid eye movement sleep behavior disorder, constipation, anxiety, and depression.
Conditions
Interventions
Placebo Control Group:Receiving the placebo compound
Probiotic Treatment Group:Receiving the probiotic compound intervention
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosis of Parkinsonian Syndrome: The patient must exhibit bradykinesia, along with at least one of the two primary features: resting tremor or rigidity. Examination of all core primary features must be conducted as specified in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The case fulfills the criteria for "Clinically Established PD" or "Clinically Probable PD" as defined in the MDS 2015 diagnostic criteria. 2.The patient is rated at stages 1-4 on the Modified Hoehn and Yahr Scale (M-H&Y); 3.The patient scores between 8 and 35 on the 24-item Hamilton Depression Scale (HAMD-24) or between 7 and 21 on the Hamilton Anxiety Scale (HAMA); 4.The patient scores >=24 on the Mini-Mental State Examination (MMSE); 5.Informed consent is obtained; 6. Age between 40 and 80 years.
Exclusion criteria
Exclusion criteria: 1.Secondary parkinsonism or atypical Parkinson's disease, Alzheimer's disease, or other central nervous system disorders; 2.Use of antibiotics or any form of probiotics within 30 days prior to the study; 3.Presence or potential risk of allergy to probiotics; 4.History of colorectal diseases or major abdominal/pelvic surgery; 5.Use of tube feeding; 6.Presence of tumors, heart failure, chronic obstructive pulmonary disease, nephritis, diarrhea, abdominal pain, inflammatory bowel disease, history of liver diseases, infectious diseases, or other severe chronic conditions at the time of enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in HAMD or HAMA score from baseline at Visit 3; | — |
Countries
China
Contacts
Public ContactBenYan Luo
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed