Using fecal microbiota transplantation to treat constipation in Parkinson's disease patients
Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation
This study is testing whether a treatment called fecal microbiota transplantation can help relieve constipation in people with Parkinson's disease who are already taking medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangzhou First People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04837313 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of fecal microbiota transplantation (FMT) for alleviating constipation symptoms in patients with Parkinson's disease who are on a stable dose of levodopa. Given that a significant number of Parkinson's patients experience constipation due to both the disease and its treatments, this trial aims to explore the potential of FMT to improve gut health and overall quality of life. Participants will be monitored for changes in their constipation symptoms and overall health following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a clinical diagnosis of Parkinson's disease and chronic constipation symptoms.
Not a fit: Patients with Parkinson's disease who do not experience constipation or are not on levodopa treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bowel function and quality of life for Parkinson's disease patients suffering from constipation.
How similar studies have performed: While the use of fecal microbiota transplantation is a relatively novel approach in this context, preliminary studies suggest potential benefits in gut health for neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Guangzhou First People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hongli Huang, MM — Guangzhou First People's Hospital
- Study coordinator: Yongjian Zhou, MM
- Email: eyzhouyongjian@scut.edu.cn
- Phone: 86-13503060150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.