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

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ClinicalTrials.gov Identifier: NCT03876327
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
ARIK SEGAL MD, Soroka University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: fecal microbial transplantation Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study
Actual Study Start Date : August 19, 2015
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : June 30, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PD patients that will receive FMT
fecal microbial transplantation once at the beginning of the study-15 patients.
 Procedure: 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.
No Intervention: PD patients that will not receive FMT
do not receive treatment-35 patients.
No Intervention: healthy people live with PD patients
do not receive treatment-50 participants.


Outcome Measures
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Primary Outcome Measures :
  1. motor parkinsonian symptoms [ Time Frame: Change from baseline motor difficulties at 6 months ]
    motor symptoms assessed by UPDRS III questionaire

  2. constipation level [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876327


Locations
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Israel
Soroka Medical Center
Be'er Sheva, Israel, 151
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: arik segal, MD SOROKA MC
More Information
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Responsible Party: ARIK SEGAL MD, Principal Investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT03876327    
Other Study ID Numbers: 0266-15-SOR
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases