KCT0006669尚未招募未知
Changes of gut microbiota by acupuncture & moxibustion in idiopathic Parkinson's disease patients: A single group, prospective, observational study
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50?(Year) 至 85?(Year)（—）
- 性别
- All
入选标准
- •[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
排除标准
- •[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.
研究者
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