Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Procedure: fecal microbial transplantation

• Registration Number: NCT03876327
• Lead Sponsor: Soroka University Medical Center

Brief Summary

this pilot study aims to further explore the potential usage of Fecal microbiota transplantation in treating constipation and possibly also motor symptoms in Parkinson's disease (PD) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and PD.

Detailed Description

Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms and Gastrointestinal dysfunction, in particular constipation, affects up to 80% of PD patients and may precede the onset of motor symptoms by years.

this study include one group of PD patients that will receive FMT. two other groups will serve as controls:

1. PD patients that will not receive FMT

2. healthy people who live with PD patients in the same house and share similar surrounding

Study Timeline

• Study Start: 2015-08-19
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Primary Completion: 2019-12-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-02
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Subjects aged > 50 years, diagnosed as suffering from PD and under follow up of the Movement Disorders Clinic in Soroka University Medical Center.
• Subjects complaining of constipation .
• Subjects who did not perform a screening colonoscopy for colon cancer.
• Subjects who are clinically undertreated according to last Movement Disorders specialist's impression at the clinic visit.

Exclusion Criteria

• Subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically.
• Subjects who already underwent a screening colonoscopy for colon cancer.
• Subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD patients that will receive FMT	fecal microbial transplantation	fecal microbial transplantation once at the beginning of the study-15 patients.

Primary Outcome Measures

Name	Time	Method
motor parkinsonian symptoms	Change from baseline motor difficulties at 6 months	motor symptoms assessed by UPDRS III questionaire
constipation level	Change from baseline constipation level at 6 months	constipation will be assessed by a scoring system questionaire. 6 parameters are reviewed as scored fro 0 (mild symptom) to 4 (srvere symptom).

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel