Parkinson's disease
Conditions
Interventions
Healthy trial group:None
Parkinson's salivation group:None
Parkinson's non salivation group:None
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Selection criteria for PD salivation patients: 1) Age range from 40 to 85 years old, regardless of gender; 2) Patients with primary Parkinson's disease meet the clinical diagnostic criteria for Parkinson's disease MDS (2016); 3) The score for item 2.6 in the second part of UPDRS is 1-4 points; 4) The motor and salivation symptoms of Parkinson's disease were stable in the first month before enrollment, and there was no adjustment in medication for all Parkinson's diseases in the first month before enrollment; Two weeks prior to enrollment, no anticholinergic drugs such as bromobistigmine, dihydroergot mesylate, or atropine were taken, and no drugs such as botulinum toxin were injected. 5) No PPI, antibiotics, probiotics or prebiotics were used for the first 2 months before enrollment. If used, a 2-month washout period should be carried out; 6) The Mini Mental State Examination (MMSE) scores>24 points. Hamilton Depression Scale score24 points. Hamilton Depression Scale score24 points. Hamilton Depression Scale score<17, Anxiety Scale score<14; 3) Before enrollment, no probiotics, prebiotics, or antibiotics were used for treatment. If used, a 2-month washout period should be followed. 4) Understand and agree to comply with the research protocol, agree to be enrolled, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for PD salivation patients: 1) Parkinson's superimposition syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, Louis body dementia, vascular Parkinson's syndrome, post encephalitis Parkinson's syndrome, or any other non primary Parkinson's disease; 2) Long term smoking history before enrollment; 3) The medication for Parkinson's disease was adjusted one month before enrollment; Taking anticholinergic drugs such as atropine and injecting botulinum toxin within one month before enrollment; 4) A history of salivary related diseases that may affect salivary secretion function, including but not limited to the following diseases: primary or secondary Sj ö gren syndrome and sarcoidosis, or organ dysfunction, such as salivary stones; 5) Severe cardiovascular diseases (such as congestive heart failure classified as Grade III-IV by the American Heart Association, history of myocardial infarction within 6 months, etc.); 6) Severe liver and kidney dysfunction; 7) Pregnant and lactating women or pregnant women aged 40-60 who are HCG positive; 8) Individuals who are known to be allergic to omeprazole enteric coated capsules or their excipients; 9) Individuals with a history of drug abuse or alcohol dependence; 10) Individuals who were participating in other clinical trials at the time of enrollment; 11) Refusal to join and inability to cooperate with researchers; The researchers determined that patients were not suitable for enrollment. 2. Exclusion criteria for PD non salivation patients: 1) Individuals with Parkinson's disease motor symptoms who meet the diagnosis of Parkinson's syndrome are included in the PD salivation group; Parkinson's superimposition syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, Louis body dementia, vascular Parkinson's syndrome, post encephalitis Parkinson's syndrome, or any other non primary Parkinson's disease; 2) Long term smoking history before enrollment; 3) The medication for Parkinson's disease was adjusted one month before enrollment; Taking anticholinergic drugs such as atropine and injecting botulinum toxin within one month before enrollment; 4) A history of salivary related diseases that may affect salivary secretion function, such as Sj ö gren syndrome and sarcoidosis, or organ dysfunction, such as salivary stones; 5) Severe cardiovascular diseases (such as congestive heart failure classified as Grade III-IV by the American Heart Association, history of myocardial infarction within 6 months, etc.); 6) Severe liver and kidney dysfunction; 7) Pregnant and lactating women or pregnant women aged 40-60 who are HCG positive; 8) Individuals who are known to be allergic to omeprazole enteric coated capsules or their excipients; 9) Individuals with a history of drug abuse or alcohol dependence; 10) Individuals who were participating in other clinical trials at the time of enrollment; 11) Refusal to join and inability to cooperate with researchers; The researchers determined that patients were not suitable for enrollment. 3. Exclusion criteria for healthy subjects: the same as the exclusion criteria for PD salivation patients and PD non salivation patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting saliva flow rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Salivary gland imaging ;Salivary biochemical test;Abundance of salivary microbiota;Abundance of fecal microbiota;Unified PD Rating Scale (UPDRS);Improved Hoehn and Yahr (H&Y) staging;Hamilton Depression Rating Scale (HAMD);Mini Mental State Scale (MMSE);Salivation Severity and Frequency Scale (DSFS);Cleveland Constipation Score;Gastrointestinal Symptom Assessment Scale;Clinical efficacy evaluation scale;Salivary gland biopsy;Hamilton Anxiety Rating Scale (HAMA); | — |
Countries
China
Contacts
Public ContactHouzhen Tuo
Beijing Friendship Hospital Affiliated to Capital Medical University
Outcome results
None listed