Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation

Launched by GUANGZHOU FIRST PEOPLE'S HOSPITAL · Apr 6, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether fecal microbiota transplantation (FMT) can help relieve constipation in people with Parkinson's disease. Constipation is a common issue for many patients with Parkinson's, affecting about 63% of them, often worsened by medications they take. The study aims to see if FMT, which involves transferring healthy bacteria from a donor's stool into a patient's digestive system, can improve their intestinal health and reduce constipation symptoms.

To participate in this trial, individuals need to be between 18 and 75 years old and have been diagnosed with Parkinson's disease for at least a year. They should also experience specific constipation symptoms, such as infrequent bowel movements or difficulty passing stool, for at least six months. Participants will receive FMT through methods like endoscopy or colonoscopy and will be monitored for safety and effectiveness during the study. This research could provide new insights into treating constipation related to Parkinson's disease, potentially helping many patients feel better.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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