Status:
UNKNOWN
Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation
Lead Sponsor:
Guangzhou First People's Hospital
Conditions:
Parkinson's Disease
Fecal Microbiota Transplantation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Parkinson's disease(PD) may cause the autonomic nervous system's improper functioning, which is responsible for regulating the intestinal tract movement. A certain degree of degeneration of digestive ...
Eligibility Criteria
Inclusion
- Between 18-75 years of age
- Signed informed consent form
- Clinical diagnosis of Parkinson's disease (according to 2016 edition of Chinese Parkinson's disease diagnostic criteria)
- Parkinson's disease duration of 1 year or more
- Hoehn \& Yahr stage 1-4 (including)
- Patients have following 2 or more symptoms, which appear for at least 6 months and exist in recent 3 months: A. at least 25% of defecation feel strenuous; B. At least 25% of defecation was not massive or hard; C. at least 25% of defecation had incomplete feeling; D. at least 25% of defecation had anorectal obstruction; E. at least 25% of defecation needed manual assistance; F. defecation less than 3 times a week, with or without abdominal pain
- Patients are taking oral L-dopa (with or without Benserazide, carbidopa, and O-methyltransferase inhibitors) at least 4 weeks, and be able to tolerate a steady dose of dopamine agonists, monoamine oxidase B inhibitors, anticholinergics, and / or adamantine.
- Patients are taking stable dosage of anti-PD drugs, antidepressant drugs and antipsychotics for more than 1 month.
- Be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.
- Be able to receive follow-up visit, follow-up examination and specimen collection on time
Exclusion
- Patients with Parkinson's syndrome and Parkinsonism plus syndrome
- History of cerebrovascular accident, brain injury, epilepsy and other brain injury
- The "opening" stage was Hoehn \& Yahr 5
- Patient received neurosurgical intervention or stereotactic brain surgery for Parkinson's disease
- Patients with organic lesions of digestive tract
- Patients had major abdominal surgery
- History of infectious diarrhea and took antibiotics in recent 2 weeks
- Patients infected with Clostridium difficile and other pathogens
- Patients with HIV or compromised immune system (such as congenital immunodeficiency or currently taking immunosuppressive drugs)
- Patients with uncontrollable basic diseases of digestive system
- Patients could not fully understand and sign the informed consent form
- Patients who were not considered suitable for inclusion in the study
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04837313
Start Date
May 1 2021
End Date
December 30 2025
Last Update
August 3 2021
Active Locations (1)
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1
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180