JRCT ID: jRCTs041220054
Registered date:15/08/2022
The effects of prebiotics on Parkinson's disease patients with wearing-off
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Parkinson's disease patients with wearing-off over 20 years old |
Date of first enrollment | 15/08/2022 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | administration of kestose and inulin Dose / Usage) Kestose: 6 g (3 g in the morning, 3 g in the evening) / 2 times a day, orally Inulin: 6g (3g in the morning, 3g in the evening) / 2 times a day, orally Administration period) 8 weeks |
Outcome(s)
Primary Outcome | Changes in gut microflora, off time (using symptom observation sheet) |
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Secondary Outcome | 1. Clinical score (MMSE: mini-mental state examination, MOCA-J: Japanese version of Montreal Cognitive Assessment, ACE-R: Addenbrooke's Cognitive Examination, GDS: Geriatric Depression Scale, SCOPA-Aut: Scales for Outcomes in Parkinson's Disease-Autonomic dysfunction, MDS-UPDRS: movement disorder society-unified Parkinson's disease rating scale, PDQ-39: Parkinson's Disease Questionnaire 39, etc.) 2. L-dopa concentration in blood 3. Analysis of fecal tdc gene concentration by quantitative PCR 4. Changes in the oral bacterial flora 5. Nutritional status (quantification of nutritional assessment protein in blood, muscle mass and body composition by body composition measuring device, and height / weight / BMI) 6. Short-chain fatty acids in blood and stool 7. Quantification of inflammation-related molecules, neurotrophic factors, energy mediators, phospholipids, etc. in blood and cerebrospinal fluid 8. Analysis of lymphocyte fractions including regulatory T cells by flow cytometry 9. Analysis of mRNA related to inflammatory cytokines in blood by real-time PCR 10. Evaluation of fecal properties (Bristol scale, etc.) 11. Evaluation of dopamine transporter distribution in the brain by dopamine transporter scintigraphy 12. Evaluation of adverse events (CTC-AE ver 5) |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Patients who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding 2. Patients over 20 years old at the time of consent 3. Parkinson's disease patients with wearing-off who exhibit at least 2.5 hours of off time per day with appropriate treatments for Parkinson's disease |
Exclude criteria | 1. Patients who have used antibiotics within 1 week of stool collection 2. Patients taking large amounts of probiotics and prebiotics on a daily basis 3. Patients who have an excessively biased diet on a daily basis (daily intake of large amounts of alcohol, extremely unbalanced diet, etc.) 4. Patients who took more than the effective intake of probiotics and prebiotics that have been reported to be functional during the intervention period. 5. Patients treated for gastrointestinal disorders during the intervention period 6. Patients judged to be inappropriate by the principal investigator or the investigator |
Related Information
Primary Sponsor | Hirooka Yoshiki |
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Secondary Sponsor | Watanabe Hirohisa |
Source(s) of Monetary Support | Nihon Medi-Physics Co.,Ltd. |
Secondary ID(s) |
Contact
Public contact | |
Name | Yasuaki Mizutani |
Address | 1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi Aichi Japan 470-1192 |
Telephone | +81-562-93-9295 |
y.m.synapse@hotmail.co.jp | |
Affiliation | Fujita Health University Hospital |
Scientific contact | |
Name | Yoshiki Hirooka |
Address | 1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi Aichi Japan 470-1192 |
Telephone | +81-562-93-2324 |
yoshiki.hirooka@fujita-hu.ac.jp | |
Affiliation | Fujita Health University Hospital |