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

NCT03876327 | Completed Phase 2

• 1 other identifier: 0266-15-SOR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• motor parkinsonian symptoms

  motor symptoms assessed by UPDRS III questionaire

  Change from baseline motor difficulties at 6 months

• 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

Study Arms (3)

PD patients that will receive FMT

EXPERIMENTAL

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

Procedure: fecal microbial transplantation

PD patients that will not receive FMT

NO INTERVENTION

do not receive treatment-35 patients.

healthy people live with PD patients

NO INTERVENTION

do not receive treatment-50 participants.

Interventions

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.

PD patients that will receive FMT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka Medical Center

Beersheba, 151, Israel

Location

Related Publications (1)

• 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.

  PMID: 34237681 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• arik segal, MD

  SOROKA MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 15, 2019
• Study Start: August 19, 2015
• Primary Completion: December 30, 2019
• Study Completion: June 30, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

IL (1)