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

August 1, 2021 updated by: Guangzhou First People's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yandi Liu, MM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parkinson's Disease with Constipation
Fecal microbiota transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou First People's Hospital

Investigators

  • Principal Investigator: Hongli Huang, MM, Guangzhou First People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

October 30, 2025

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

December 20, 2020

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-2020-107-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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