Parkinson's disease patients with wearing-off over 20 years old
Conditions
Interventions
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, ora
Sponsors
Hirooka Yoshiki
Watanabe Hirohisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in gut microflora, off time (using symptom observation sheet) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactYasuaki Mizutani
Fujita Health University Hospital
Outcome results
None listed