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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

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE August 19, 2015
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • motor parkinsonian symptoms [ Time Frame: Change from baseline motor difficulties at 6 months ]
    motor symptoms assessed by UPDRS III questionaire
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease
Official Title  ICMJE Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Parkinson Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: PD patients that will receive FMT
    fecal microbial transplantation once at the beginning of the study-15 patients.
    Intervention: Procedure: fecal microbial transplantation
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
100
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876327
Other Study ID Numbers  ICMJE 0266-15-SOR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party ARIK SEGAL MD, Soroka University Medical Center
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: arik segal, MD SOROKA MC
PRS Account Soroka University Medical Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP