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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876327
• Other study ID #: 0266-15-SOR
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 19, 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Be'er Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	motor parkinsonian symptoms	motor symptoms assessed by UPDRS III questionaire	Change from baseline motor difficulties at 6 months
Primary	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