Fecal Microbiota Transplantation for Parkinson's Disease

NCT03808389 | Completed

• 1 other identifier: UGent2018/0623
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Parkinson's disease; Fecal microbiota transplantation; Microbiome; Gut-brain axis

Outcome Measures

Primary Outcomes (1)

• Changes in clinical symptoms as scored on the MDS-UPDRS (Movement Disorder Society - Unified Parkinson's Disease Rating Scale)

  The MDS-UPDRS (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) has four parts: Part I (non-motor experiences of daily living; 13 items), Part II (motor experiences of daily living; 13 items), Part III (motor examination; 33 scores based on 18 items, several with right, left or other body distribution scores) and Part IV (motor complications; 6 items). Each item has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Part III will be clinically scored in an OFF-medication state. Subscales are analyzed separately. References: 1. Goetz, C. et al. Movement Disord 22, 41-47 (2007). 2. Goetz, C. et al. Movement Disord 23, 2129-2170 (2008).

  3 months, 6 months, 12 months

Secondary Outcomes (5)

• Changes in non-motors symptoms as scored on the Non-motor symptoms scale for Parkinson's disease (NMSS)

  3 months, 6 months, 12 months

• Changes in quality of life as scored on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)

  3 months, 6 months, 12 months

• Changes in cognition as scored on the Montreal Cognitive Assessment (MoCA)

  3 months, 6 months, 12 months

• Number of participants with a change in required anti-PD symptomatic or levodopa therapy

  3 months, 6 months, 12 months

• Changes in gastrointestinal symptoms as assessed by the Rome IV questionnaire

  3 months, 6 months, 12 months

Study Arms (2)

Treatment group: Donor FMT

EXPERIMENTAL

Fecal microbiota transplantation using fecal matter from a healthy donor selected through strict inclusion criteria assessing the presence of any infectious diseases.

Other: Donor FMT

Control group: Autologous FMT

SHAM COMPARATOR

Fecal microbiota transplantation using the patient's own fecal matter.

Other: Autologous FMT

Interventions

Donor FMT OTHER

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.

Also known as: FMT with donor stool

Treatment group: Donor FMT

Autologous FMT OTHER

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.

Also known as: FMT with own stool

Control group: Autologous FMT

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Clinical PD diagnosis (MDS criteria)
• Hoehn \& Yahr score of 2-3 in OFF
• Age of motor symptoms onset \> 50 years

You may not qualify if:

• First degree relative or more than one relative with PD
• Diagnosis of dementia or MMSE \< 25
• Diagnosis of major depression or psychosis (DSM-V criteria)
• Any of the following within the previous 2 months: hospital admission, narcosis or sedation, abdominal trauma
• Primary disease of gastrointestinal tract (exception: chronic gastritis)
• Previous abdominal or anorectal surgery (causing structural abnormalities of the intestines)
• Any of the following within the previous 2 months: gastrointestinal or respiratory tract infection, food intoxication
• The use of probiotics or antibiotics within three months prior to FMT
• Contra-indications for colonoscopy
• Other immune disorder or clinical immunosuppression
• Drug abuse
• Malignancy
• Any severe comorbidity that might interfere with the study course as determined by the treating physician
• Pregnancy or inadequate anti conception for the duration of the trial
• age 18 - 75 years

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator
• the Flanders Institute for Biotechnology: collaborator
• Research Foundation Flanders: collaborator
• Vlaamse Parkinson Liga: collaborator
• Parkili: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

• Bruggeman A, Vandendriessche C, Hamerlinck H, De Looze D, Tate DJ, Vuylsteke M, De Commer L, Devolder L, Raes J, Verhasselt B, Laukens D, Vandenbroucke RE, Santens P. Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial. EClinicalMedicine. 2024 Mar 27;71:102563. doi: 10.1016/j.eclinm.2024.102563. eCollection 2024 May.

  PMID: 38686220 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Patrick Santens, MD, PhD

  Ghent University, Ghent University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 40 patients with Parkinson's disease (Hoehn \& Yahr score 2-3) will be randomly allocated (20 vs. 20) to either fecal microbiota transplantation with donor stool or autologous fecal microbiota transplantation (= own stool).

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: January 17, 2019
• Study Start: December 1, 2020
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)