Fecal Microbiota Transplantation for Parkinson's Disease

Summary

Parkinson's disease (PD) is the second most common neurodegenerative disorder and due to the lack of early diagnosis and effective therapy, represents a large burden for our society and healthcare system. The last years, it became increasingly apparent that non-motor symptoms, including gastrointestinal dysfunction, precede the onset of the typical PD motor symptoms by several years. Moreover, emerging evidence suggests that PD, and more specifically the aggregation of alpha-synuclein, starts in the gut before spreading to the brain. Additionally, recent microbiome studies consistently showed microbiota differences between PD patients and healthy controls.

The ultimate goal of this project is to address the impact of gut dysbiosis and the restoration of gut homeostasis by fecal microbiota transplantation (FMT) on the development and progression of PD. We will identify PD-specific changes in microbiota composition and gut inflammation and determine the effect of a 'microbiome-reset' approach through FMT in PD patients on the identified changes and more importantly on disease symptoms and progression.

Conditions

• Parkinson Disease

Interventions

OTHER

Donor FMT

Fecal microbiota transplantation through nasojejunal administration. Fecal matter will be collected prior to the start of the study from healthy donors and will be frozen at -80°C after thorough screening for infectious diseases. At the time of transplantation, samples will be thawed and administrated to the patients in the treatment group.

OTHER

Autologous FMT

Fecal microbiota transplantation through nasojejunal administration. Fecal matter will be collected prior to the start of the study from each patient and will be frozen at -80°C after thorough screening for infectious diseases. At the time of transplantation, samples will be thawed and administrated to the patients in the control group.

Sponsors & Collaborators

• University Hospital, Ghent

  collaborator OTHER

• the Flanders Institute for Biotechnology

  collaborator UNKNOWN

• Research Foundation Flanders

  collaborator OTHER

• Vlaamse Parkinson Liga

  collaborator UNKNOWN

• Parkili

  collaborator UNKNOWN

• University Ghent

  lead OTHER

Principal Investigators

• Patrick Santens, MD, PhD · Ghent University, Ghent University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2022-12-09

Completion

2022-12-09

Countries

• Belgium

Study Locations