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

Study Overview
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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.

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: PD patients that will not receive FMT healthy people who live with PD patients in the same house and share similar surrounding

Official Title
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Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: fecal microbial transplantation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 groups were included in the study: PD patients that will undergo FMT tretment and a half of year follow-up-15 patients. PD patients that will not undergo FMT procedure and will donate stool sample only once-35 patients. healthy PD relatives, that live with them and have similiar life styling and which will donate stool sample only once-50 participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD patients that will receive FMT<br>fecal microbial transplantation once at the beginning of the study-15 patients. | Procedure: fecal microbial transplantation<br>* 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.<br>|
| No Intervention: PD patients that will not receive FMT<br>do not receive treatment-35 patients. | |
| No Intervention: healthy people live with PD patients<br>do not receive treatment-50 participants. | |

What is the study measuring?
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Primary Outcome Measures

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