A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients

October 8, 2024 updated by: Filip Scheperjans, Helsinki University Central Hospital

A Randomized, Double Blind, Placebo Controlled Multicenter Trial of Fecal Microbiome Transplantation Safety and Efficacy for Parkinson's Disease Patients with Abnormal Gut Microbiota Composition

48 PD patients (age 35-75y; H&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Lahti, Finland
        • Päijät-Häme Central Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of idiopathic PD (Clinically Probable PD)
  • H&Y OFF 1-3 at Baseline Visit

Exclusion Criteria:

  1. Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed)
  2. Any previous major gastrointestinal surgery that may alter gastrointestinal physiology
  3. Any abdominal surgery in the last 3 months
  4. Major genital and/or rectum prolapse
  5. Active autoimmune disease
  6. Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ)
  7. Immune deficiency
  8. HIV infection
  9. Antibiotic use in last 3 months before baseline visit
  10. Dementia as indicated by Moca <21p
  11. Psychosis
  12. Active significant impulse control disorder (by interview and medical records)
  13. Major depression as indicated by BDI-II >28
  14. Pregnancy
  15. Alcohol or drug abuse
  16. Negative dysbiosis test result
  17. Iodine allergy
  18. Deep brain stimulation or Duodopa/Lecigon treatment
  19. Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Donor FMT
FMT from a healthy donor
Other: Administration of donor FMT
Intracaecal infusion of FMT
Placebo Comparator: Placebo
NaCl + glycerol mixture (carrier solution of FMT arm)
Other: Administration of placebo
Intracaecal infusion of carrier solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of the sum of MDS-UPDRS I-III from baseline
Time Frame: at 6 months post intervention
Sum of Movement Disorder Society Unified Parkinson's Disease Rating Scale sum of parts I, II, and III (in OFF state); Min 0 - Max 236 points (higher points indicating worse symptoms) will be determined at baseline and at 6 months after intervention. The difference between these values will be the primary outcome measure; Min 0 - Max 236 points (higher points indicating stronger improvement)
at 6 months post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of MDS-UPDRS III from baseline
Time Frame: at 6 and 12 months post intervention
Movement Disorder Society Unified Parkinson's Disease Rating Scale part III (in OFF state); Min 0 - Max 132 points (higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 132 points (higher points indicating stronger improvement)
at 6 and 12 months post intervention
Change of MDS-UPDRS IV from baseline
Time Frame: at 6 and 12 months post intervention
Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV; Min 0 - Max 132 points (higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 24 points (higher points indicating stronger improvement)
at 6 and 12 months post intervention
Change of Timed UP GO test from baseline
Time Frame: at 6 and 12 months post intervention
measured in seconds, higher value indicating worse clinical symptoms expressed as difference between 6 and 12 month post intervention and baseline, higher value indicating stronger improvement
at 6 and 12 months post intervention
Change of MDS-UPDRS I from baseline
Time Frame: at 6 and 12 months post intervention
Movement Disorder Society Unified Parkinson's Disease Rating Scale part I; Min 0 - Max 52 points (higher points indicating worse symptoms) will be determined at baseline and at 6 months after intervention. The difference between these values will be calculated; Min 0 - Max 52 points (higher points indicating stronger improvement)
at 6 and 12 months post intervention
Change of NMSS from baseline
Time Frame: at 6 and 12 months post intervention
Non-motor symptom scale (0-360 points, higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 360 points (higher points indicating stronger improvement)
at 6 and 12 months post intervention
Change in gut permeability, motility and volume from baseline
Time Frame: at 6 months
Gut permability is studied using the Iohexole test.Motility and volume is studied using radio-opaque markers and volume measurments from abdominal CT scans
at 6 months
Change of fecal and blood markers from baseline
Time Frame: whole study period
Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation
whole study period
Change of BDI-II from baseline
Time Frame: at 6 and 12 months post intervention
Beck Depression Inventory II (0-63 points, higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 63 points (larger decrease indicating stronger improvement)
at 6 and 12 months post intervention
Change of BAI from baseline
Time Frame: at 6 and 12 months post intervention

Beck Anxiety inventory will be determined at baseline and at 6 and 12 months after intervention.

The difference between these values will be calculated; Min 0 - Max 63 points (larger decrease indicating stronger improvement)
at 6 and 12 months post intervention
Change of RBDSQ from baseline
Time Frame: at 6 and 12 months after intervention
REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention.
at 6 and 12 months after intervention
Change of MoCa from baseline
Time Frame: at 6 and 12 months post intervention
MONTREAL COGNITIVE ASSESSMENT (0-30 points, higher points indicating less symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 30 points (higher increase indicating stronger improvement)
at 6 and 12 months post intervention
Change of IBS-SSS from baseline
Time Frame: at 6 and 12 months after intervention
The irritable bowel severity scoring system will be determined at baseline and follow-up
at 6 and 12 months after intervention
Change of PDQ39 index from baseline
Time Frame: at 6 and 12 months post intervention
Parkinson's Disease Questionnaire 39 index (0-100 points, higher points indicating worse quality of life) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 100 points (larger decrease indicating stronger improvement)
at 6 and 12 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
University of Aarhus
University of Helsinki
Tampere University Hospital
Central Hospital of Paijat-Hame

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Filip Scheperjans, MD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PD-FMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw sequencing reads will be uploaded to the European Nucleotide Archive. Upon reasonable request and execution of a data transfer agreement we will share de-identified clinical data and metadata in the range that is permitted by local legislation.

IPD Sharing Time Frame

After publication of the results for indeterminate time.

IPD Sharing Access Criteria

Upon reasonable request and execution of a data transfer agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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