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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837313
• Other study ID #: K-2020-107-02
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2020
• Source: Guangzhou First People's Hospital
• Contact: Yongjian Zhou, MM
• Phone: 86-13503060150
• Email: eyzhouyongjian[@]scut.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Fecal Microbiota Transplantation
• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• Fecal Microbiota Transplantation
Fecal Microbiota Transplantation

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. Erratum in: Front Neurol. 2020 Feb 06;10:1412. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The data will be collected in several time points from baseline to 6 months after FMT. Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom.; Wexner Constipation Scoring system is a scale to evaluate the severity of constipation. These factors included frequency of bowel movements, painful evacuation, incomplete evacuation, abdominal pain, length of time per attempt, assistance for evacuation, unsuccessful attempts for evacuation per 24 hours, and duration of constipation, with 0 indicating normal and 30 indicating severe constipation.	6 months
Secondary	The improvement of clinical symptoms in patients with Parkinson's Disease will be assessed by the change of several scales of Parkinson's Disease.		6 months