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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-19

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 groups were included in the study:

1. PD patients that will undergo FMT tretment and a half of year follow-up-15 patients.
2. PD patients that will not undergo FMT procedure and will donate stool sample only once-35 patients.
3. healthy PD relatives, that live with them and have similiar life styling and which will donate stool sample only once-50 participants.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD patients that will receive FMT

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

Group Type EXPERIMENTAL

fecal microbial transplantation

Intervention Type PROCEDURE

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.

PD patients that will not receive FMT

do not receive treatment-35 patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

healthy people live with PD patients

do not receive treatment-50 participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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fecal microbial transplantation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes