Skip to main content
OpenTrials
Completed

NCT Number: NCT03876327

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Soroka Medical Center

Beersheba, 151, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fecal microbial transplantation

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.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.