Parkinson's disease
Conditions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form; 2. Aged 18-75 years; 3. First clinical diagnosis?of Parkinson's disease (MDS criteria); 4. Hoehn & Yahr stage 2-3 (including); 5. Carrying only LRRK2 associated variants after genetic analysis; 6. Never-medicated for Parkinsons disease.
Exclusion criteria
Exclusion criteria: 1. First degree relative or more than one relative with PD; 2. Diagnosis of major depression or psychosis (DSM-V criteria); 3. Diagnosis of a significant neurologic disease other than PD; 4. Any of the following within the previous 2 months: hospital admission, narcosis or sedation, abdominal trauma; 5. Primary disease of gastrointestinal tract (exception: chronic gastritis); 6. Previous abdominal or anorectal surgery (causing structural abnormalities of the intestines); 7. Any of the following within the previous 2 months: gastrointestinal or respiratory tract infection, food intoxication; 8. The use of probiotics or antibiotics within three months prior to FMT; 9. Contra-indications for colonoscopy; 10. Other immune disorder or clinical immunosuppression; 11. Drug abuse; 12. Malignancy; 13. Any severe comorbidity that might interfere with the study course as determined by the treating physician; 14. Pregnancy or inadequate anti conception for the duration of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDS UPDRS;Hoehn & Yahr stage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Constipation scoring system (CSS) before and after FMT and follow-up;Gastrointestinal symptom rating scale (GSRS) before and after FMT and follow-up;Scales for outcomes in Parkinson’s disease-autonomic (SCOPA-AUT) before and after FMT and follow-up ;Non-motor symptoms scale (NMSS) before and after FMT and follow-up;Fatigue severity scale (FSS) before and after FMT and follow-up;Rapid eye movement sleep behavior disorder (RBDQ-HK) before and after FMT and follow-up; Hyposmia rating scale (HRS) before and after FMT and follow-up;The Hamilton anxiety scale (HAMA) before and after FMT and follow-up;The Hamilton depression scale, HAMD) before and after FMT and follow-up;Mini-mental state examination (MMSE) before and after FMT and follow-up;Montreal Cognitive Assessment before and after FMT and follow-up;Parkinson’s disease questionnaire 39 item (PDQ-39) before and after FMT and follow-up;Gastrointestinal pathology before and after FMT and follow-up before and after FMT and follow-up;Neurotransmitters levels before and after FMT and follow-up;Gut microbiome before and after FMT and follow-up; | — |
Countries
China
Contacts
Public ContactJunfang Teng
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed