Back to resultsA Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Administration of donor FMT
Administration of placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, FMT, microbiota, gut-brain axis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic PD (Clinically Probable PD)
- H&Y OFF 1-3 at Baseline Visit
Exclusion Criteria:
- Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed)
- Any previous major gastrointestinal surgery that may alter gastrointestinal physiology
- Any abdominal surgery in the last 3 months
- Major genital and/or rectum prolapse
- Active autoimmune disease
- Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ)
- Immune deficiency
- HIV infection
- Antibiotic use in last 3 months before baseline visit
- Dementia as indicated by Moca <21p
- Psychosis
- Active significant impulse control disorder (by interview and medical records)
- Major depression as indicated by BDI-II >28
- Pregnancy
- Alcohol or drug abuse
- Negative dysbiosis test result
- Iodine allergy
- Deep brain stimulation or Duodopa/Lecigon treatment
- Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments
Sites / Locations
- Helsinki University Central Hospital
- Päijät-Häme Central Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Donor FMT
Placebo
Arm Description
FMT from a healthy donor
NaCl + glycerol mixture (carrier solution of FMT arm)
Outcomes
Primary Outcome Measures
Change of the sum of MDS-UPDRS I-III from baseline
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)
Secondary Outcome Measures
Change of MDS-UPDRS III from baseline
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)
Change of MDS-UPDRS IV from baseline
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)
Change of Timed UP GO test from baseline
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
Change of MDS-UPDRS I from baseline
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)
Change of NMSS from baseline
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)
Change in gut permeability, motility and volume from baseline
Gut permability is studied using the Iohexole test.Motility and volume is studied using radio-opaque markers and volume measurments from abdominal CT scans
Change of fecal and blood markers from baseline
Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation
Change of BDI-II from baseline
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)
Change of BAI from baseline
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)
Change of RBDSQ from baseline
REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention.
Change of MoCa from baseline
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)
Change of IBS-SSS from baseline
The irritable bowel severity scoring system will be determined at baseline and follow-up
Change of PDQ39 index from baseline
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)
Full Information
NCT ID
NCT04854291
First Posted
April 13, 2021
Last Updated
September 21, 2023
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04854291
Brief Title
A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2021 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
June 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, FMT, microbiota, gut-brain axis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Donor FMT
Arm Type
Experimental
Arm Description
FMT from a healthy donor
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NaCl + glycerol mixture (carrier solution of FMT arm)
Intervention Type
Other
Intervention Name(s)
Administration of donor FMT
Intervention Description
Intracaecal infusion of FMT
Intervention Type
Other
Intervention Name(s)
Administration of placebo
Intervention Description
Intracaecal infusion of carrier solution
Primary Outcome Measure Information:
Title
Change of the sum of MDS-UPDRS I-III from baseline
Description
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)
Time Frame
at 6 months post intervention
Secondary Outcome Measure Information:
Title
Change of MDS-UPDRS III from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
Title
Change of MDS-UPDRS IV from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
Title
Change of Timed UP GO test from baseline
Description
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
Time Frame
at 6 and 12 months post intervention
Title
Change of MDS-UPDRS I from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
Title
Change of NMSS from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
Title
Change in gut permeability, motility and volume from baseline
Description
Gut permability is studied using the Iohexole test.Motility and volume is studied using radio-opaque markers and volume measurments from abdominal CT scans
Time Frame
at 6 months
Title
Change of fecal and blood markers from baseline
Description
Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation
Time Frame
whole study period
Title
Change of BDI-II from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
Title
Change of BAI from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
Title
Change of RBDSQ from baseline
Description
REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention.
Time Frame
at 6 and 12 months after intervention
Title
Change of MoCa from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
Title
Change of IBS-SSS from baseline
Description
The irritable bowel severity scoring system will be determined at baseline and follow-up
Time Frame
at 6 and 12 months after intervention
Title
Change of PDQ39 index from baseline
Description
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)
Time Frame
at 6 and 12 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic PD (Clinically Probable PD)
H&Y OFF 1-3 at Baseline Visit
Exclusion Criteria:
Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed)
Any previous major gastrointestinal surgery that may alter gastrointestinal physiology
Any abdominal surgery in the last 3 months
Major genital and/or rectum prolapse
Active autoimmune disease
Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ)
Immune deficiency
HIV infection
Antibiotic use in last 3 months before baseline visit
Dementia as indicated by Moca <21p
Psychosis
Active significant impulse control disorder (by interview and medical records)
Major depression as indicated by BDI-II >28
Pregnancy
Alcohol or drug abuse
Negative dysbiosis test result
Iodine allergy
Deep brain stimulation or Duodopa/Lecigon treatment
Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Scheperjans, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Päijät-Häme Central Hospital
City
Lahti
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
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