Changes of gut microbiota by acupuncture & moxibustion in Parkinson's disease patients
- Conditions
- Diseases of the nervous system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
[Patients with Parkinson's disease]
1. Men and women aged 50 to 85 years
2. Idiopathic Parkinson's disease patients who have been taking antiparkinson agents(excluding anti-cholinergics) for more than 5 years
3. Hoehn & Yahr stage 2-3
4. Patients who have no cause of cognitive or motor impairment other than Parkinson's disease
5. Patients who have voluntarily agreed to participate
6. Patients who have not participated in other clinical trials within the last 1 month
[Healthy volunteer]
1. Men and women aged 50 to 85 years
2. Participants who have no problems with cognitive function and who have voluntarily agreed to participate in the study through written consent
3. Participants who selected to match the Patients with Parkinson's disease group with age, sex, and other health conditions excluding the diagnosis of Parkinson's disease
[Patients with Parkinson's disease]
1. Patients diagnosed with secondary Parkinsonism or atypical Parkinsonian syndrome
2. Oral antibiotics taking that may affect results within the past month
3. A loss of consciousness for more than an hour due to head trauma
4. Patient with severe vision or hearing problem
5. Probiotics taking that may affect results within the past month
6. Medication(analgesics, anti-inflammatory drugs, anti-biotics, etc.) taking that may affect gastrointestinal systems within a week from the time of fecal sampling
7. Previous history of severe heart disease(myocardial infarction, heart failure, etc.)
8. Patients with a medical history of neurosurgical procedure(e.g., deep brain stimulation)
9. Patients who have been diagnosed or treated cancer
10. Patients with Glaucoma
11. Chronic alcohol consumption or drug abuse
12. Women who are pregnant or breastfeeding
13. Patients with disease such as coagulation disorder that cannot be treated for acupuncture
14. Patients suffering from clinically significant psychiatric symptoms or medical diseases
15. Participants who are judged by investigator to be nonconformity for participation in the trial for any reason
[Healthy volunteer]
1. Participants diagnosed with Parkinson's disease.
2. Participants who have taken oral antibiotics, etc. within the past one month, and it is assumed that this medication could affect the result of present study.
3. Participants with a past history of loss of consciousness for more than 1 hour due to brain trauma.
4. Participants with vision or hearing problems to the extent that the examination cannot proceed smoothly.
5. Participants who have taken a health functional food such as lactobacillus within the last 1 month, and it is assumed that this health functional food could affect the result of present study.
6. Participants who took medications that could affect the gastrointestinal tract, such as pain relievers, anti-inflammatory drugs, and antibiotics, within 1 week of stool collection
7. Participants with a history of serious heart disease such as myocardial infarction or heart failure.
8. Participants with a history of malignant tumor.
9. Participants with a history of glaucoma.
10. Participants with a history of chronic alcohol or substance abuse.
11. Participants with clinically significant psychiatric symptoms or medical conditions.
12. In case the investigator judges that he/she is physically and mentally inappropriate to participate in the clinical trial based on other laboratory findings, etc.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MDS-UPDRS (The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale) score
- Secondary Outcome Measures
Name Time Method Berg Balance test;Timed Up and Go test;Schwab & England ADL test;PDQ-39 (The Parkinson's Disease Questionnaire-39);MYMOP (Measure Yourself Medical Outcome Profile);Bristol stool scale;Gastrointestinal Symptom Rating Scale;Changes in Gut Microbiota–Related Metabolites;Gut microbiome