Clinical trial NCT04837313: Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation
Official title: Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Fecal Microbiota Transplantation
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 system function can cause PD patients to constipation symptoms. Studies have shown that up to 63 percent of people with Parkinson's disease experience constipation. What is more, medications for PD, including levodopa and dopamine agonist, can also cause constipation. In recent years, an increasing number of studies have been conducted to investigate gut microflora and their influence on the central nervous system. Furthermore, some studies of Parkinson's disease have confirmed that gut microflora plays a vital role in the occurrence and development of Parkinson's disease.

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.


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

Primary outcomes:
measure: The Efficacy of FMT in patients with constipation will be assessed by the change of The Gastrointestinal Symptom Rating Scale (GSRS) and Wexner Constipation Score.
timeFrame: 6 months
Secondary outcomes:
measure: The improvement of clinical symptoms in patients with Parkinson's Disease will be assessed by the change of several scales of Parkinson's Disease.
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital
name: Hongli Huang, MM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.