Parkinson's disease
Conditions
Interventions
Nasogastric tube infusion of fecal microbiota:Infuse fecal suspension into the duodenum via a nasointestinal tube
Colonoscopy for fecal microbiota transplantation:Introduce the fecal solution into the cecum through the colonoscopy
Control group(Standard Treatment Group):Conventional drug therapy without fecal microbiota transplantation.
Sponsors
The No.1 People's Hospital of Xiangyang, Affiliated to Hubei University of Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for primary Parkinson's disease (PD); (2) Fulfilling the Rome III diagnostic criteria for functional constipation; (3) Constipation symptoms are severe and affect the quality of life; (4) In Hoehn-Yahr stages 2-4; (5) The patients or their legal guardians fully understand the process and mechanism of fecal microbiota transplantation (FMT) treatment, agree to participate in this trial, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) With cognitive impairment and severe other neurological diseases; (2) With organic intestinal diseases and having undergone intestinal surgery; (3) With metabolic disorders affecting intestinal motility, such as thyroid dysfunction or diabetes; (4) With immune function abnormalities; (5) With severe heart, liver, or kidney dysfunction; (6) Cannot tolerate colonoscopy; (7) Over the age of 80; (8) With a history of significant brain trauma, cerebral palsy, encephalitis, or other organic brain diseases; (9) With using of antibiotic within the last 6 weeks or having participated in other drug trials within the last 3 months; (10) Severely immunosuppressed individuals (neutrophils <1500/mm^3, lymphocytes <500/mm^3), and with congenital or acquired immunodeficiency diseases; (11) With severe systemic infections meeting the diagnostic criteria for systemic inflammatory response syndrome (SIRS); (12) Having recently received high-risk immunosuppressive/cytotoxic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale I-III;Hoehn and Yahr Staging Scale;"Substantive, Behavioral, and Methological" framework; | — |
Secondary
| Measure | Time frame |
|---|---|
| receptor-associated microbial diversity;Wexner Constipation Score;Patient-assessed Constipation Quality of Life;Parkinson's Disease Questionnaire - 39;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Parkinson's Disease Non-Motor Symptoms Scale; | — |
Countries
China
Contacts
Public ContactPuqing Wang
Xiangyang No.1 People's Hospital
Outcome results
None listed