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

Soroka University Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Procedure: fecal microbial transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03876327

0266-15-SOR

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

PD patients that will receive FMT

Experimental group

Description:

fecal microbial transplantation once at the beginning of the study-15 patients.

Treatment:

Procedure: fecal microbial transplantation

PD patients that will not receive FMT

No Intervention group

Description:

do not receive treatment-35 patients.

healthy people live with PD patients

No Intervention group

Description:

do not receive treatment-50 participants.