Last reviewed · How we verify
Role and Mechanism of Bifidobacterium Triple Viable Capsules in Improving Motor Symptoms in Patients With Mild to Moderate Parkinson's Disease: a Multicenter Randomized Clinical Study
This study is a multicenter randomized double-blind placebo-controlled study. The research content is 1. The improvement effect of Bifidobacterium triple viable capsules（BIFICO） on motor symptoms and constipation and sleep in mild to moderate Parkinson's disease and the safety of the study; 2. the mechanism of the improvement effect of intestinal microecological changes on motor and constipation symptoms in mild to moderate Parkinson's disease.
Details
| Lead sponsor | Beijing Friendship Hospital |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 240 |
| Start date | 2021-11-11 |
| Completion | 2023-12 |
Conditions
- Parkinson Disease
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Brain Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Central Nervous System Diseases
- Nervous System Diseases
Interventions
- Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules
- Placebo
Primary outcomes
- Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS)Ⅱ+Ⅲ — 12 weeks
Part Ⅱ：This measures the motor aspects of activity of daily living and consists of 13 items with scores between 0- 52. Part Ⅲ：This measures the severity of motor symptoms using 18 items (score 0-72). Higher score indicates high severity.
Countries
China