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CompletedNCT03876327Updated Aug 5, 2020

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

A Phase 2/3 interventional study of fecal microbial transplantation in Parkinson Disease, sponsored by Soroka University Medical Center. Completed at 1 site in Israel. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Soroka University Medical Center · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Aug 2015, registered Feb 2019).
Phase
Phase 2/3
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.

This study's enrollment of 10 is below the median of 40 across 3,295 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    PD patients that will receive FMT

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

    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.

Interventions

  • Procedurefecal 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.

06

What researchers measure

Primary outcomes

  1. motor parkinsonian symptoms

    motor symptoms assessed by UPDRS III questionaire

    Time frame: Change from baseline motor difficulties at 6 months

  2. 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).

    Time frame: Change from baseline constipation level at 6 months

07

Study locations

1 site
  • Soroka Medical Center
    Be'er Sheva, 151, Israel
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References and documents

Publications

  • Segal A, Zlotnik Y, Moyal-Atias K, Abuhasira R, Ifergane G. Fecal microbiota transplant as a potential treatment for Parkinson's disease - A case series. Clin Neurol Neurosurg. 2021 Aug;207:106791. doi: 10.1016/j.clineuro.2021.106791. Epub 2021 Jun 30. PubMed 34237681 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03876327
Lead sponsor
Soroka University Medical Center
Responsible party
ARIK SEGAL MD (Principal Investigator, Soroka University Medical Center) — Principal investigator
First posted
Mar 15, 2019
Start date
Aug 19, 2015
Primary completion
Dec 30, 2019
Completion
Jun 30, 2020
Last update
Aug 5, 2020

Study contacts

arik segal, MD
principal investigator · SOROKA MC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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