Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation
NCT ID: NCT04837313
Last Updated: 2021-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-05-01
2025-12-30
Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of fecal microbiota transplantation in the treatment of constipation symptoms in patients with Parkinson's disease receiving a steady dose of levodopa. We will also analyze intestinal flora diversity in patients with Parkinson's disease with constipation. The investigation of the gut microbiome may emerge as a new therapeutic measure to treat constipation associate with Parkinson's disease.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Parkinson's Disease with Constipation
Fecal microbiota transplantation will be performed.
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation
Interventions
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Fecal Microbiota Transplantation
Fecal Microbiota Transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Guangzhou First People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Hongli Huang, MM
Role: PRINCIPAL_INVESTIGATOR
Guangzhou First People's Hospital
Locations
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Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Baizabal-Carvallo JF. Gut microbiota: a potential therapeutic target for Parkinson's disease. Neural Regen Res. 2021 Feb;16(2):287-288. doi: 10.4103/1673-5374.290896. No abstract available.
Bhattarai Y, Kashyap PC. Parkinson's disease: Are gut microbes involved? Am J Physiol Gastrointest Liver Physiol. 2020 Nov 1;319(5):G529-G540. doi: 10.1152/ajpgi.00058.2020. Epub 2020 Sep 2.
Dutta SK, Verma S, Jain V, Surapaneni BK, Vinayek R, Phillips L, Nair PP. Parkinson's Disease: The Emerging Role of Gut Dysbiosis, Antibiotics, Probiotics, and Fecal Microbiota Transplantation. J Neurogastroenterol Motil. 2019 Jul 1;25(3):363-376. doi: 10.5056/jnm19044.
Mhyre TR, Boyd JT, Hamill RW, Maguire-Zeiss KA. Parkinson's disease. Subcell Biochem. 2012;65:389-455. doi: 10.1007/978-94-007-5416-4_16.
Yang D, Zhao D, Ali Shah SZ, Wu W, Lai M, Zhang X, Li J, Guan Z, Zhao H, Li W, Gao H, Zhou X, Yang L. The Role of the Gut Microbiota in the Pathogenesis of Parkinson's Disease. Front Neurol. 2019 Nov 6;10:1155. doi: 10.3389/fneur.2019.01155. eCollection 2019.
Stocchi F, Torti M. Constipation in Parkinson's Disease. Int Rev Neurobiol. 2017;134:811-826. doi: 10.1016/bs.irn.2017.06.003. Epub 2017 Jul 13.
Other Identifiers
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K-2020-107-02
Identifier Type: -
Identifier Source: org_study_id
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