search
Back to results

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

Primary Purpose

Parkinson's Disease, Fecal Microbiota Transplantation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
Guangzhou First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parkinson's Disease with Constipation

Arm Description

Fecal microbiota transplantation will be performed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The improvement of clinical symptoms in patients with Parkinson's Disease will be assessed by the change of several scales of Parkinson's Disease.

Full Information

First Posted
December 20, 2020
Last Updated
August 1, 2021
Sponsor
Guangzhou First People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04837313
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's Disease with Constipation
Arm Type
Experimental
Arm Description
Fecal microbiota transplantation will be performed.
Intervention Type
Procedure
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
Fecal Microbiota Transplantation
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The improvement of clinical symptoms in patients with Parkinson's Disease will be assessed by the change of several scales of Parkinson's Disease.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongjian Zhou, MM
Phone
86-13503060150
Email
eyzhouyongjian@scut.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Huang, MM
Phone
86-13631316718
Email
honglisums@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongli Huang, MM
Organizational Affiliation
Guangzhou First People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjian Zhou, MM
Phone
86-13503060150
Email
eyzhouyongjian@scut.edu.cn
First Name & Middle Initial & Last Name & Degree
Hongli Huang, MM
Phone
86-13631316718
Email
honglisums@126.com
First Name & Middle Initial & Last Name & Degree
Yandi Liu, MM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32859778
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.
Results Reference
background
PubMed Identifier
32877215
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.
Results Reference
background
PubMed Identifier
31327219
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.
Results Reference
background
PubMed Identifier
23225012
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.
Results Reference
background
PubMed Identifier
31781020
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. Erratum In: Front Neurol. 2020 Feb 06;10:1412.
Results Reference
background
PubMed Identifier
28805584
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs