Parkinson DiseaseNCT04854291
A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
A study testing Administration of donor FMT in people with Parkinson Disease, run by Helsinki University Central Hospital at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Administration of donor FMT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 4 sitesFinland
- Study dates
- 25 Apr 2021to 13 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD (Clinically Probable PD)
- H\&Y OFF 1-3 at Baseline Visit
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Helsinki University Central Hospital
Helsinki
Päijät-Häme Central Hospital
Lahti
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- Administration of donor FMT, Administration of placebo
- Keywords
- Parkinson's disease, FMT, microbiota, gut-brain axis
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of donor FMTOther
Intracaecal infusion of FMT
Administration of placeboOther
Intracaecal infusion of carrier solution
| Study group | Role | What they receive |
|---|---|---|
| Donor FMT | Experimental | FMT from a healthy donor Receives: Other: Administration of donor FMT |
| Placebo | Placebo comparator | NaCl + glycerol mixture (carrier solution of FMT arm) Receives: Other: Administration of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 6 months post intervention
Secondary outcomes (13)
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)
Measured: at 6 and 12 months post intervention
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)
Measured: at 6 and 12 months post intervention
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
Measured: at 6 and 12 months post intervention
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)
Measured: at 6 and 12 months post intervention
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)
Measured: at 6 and 12 months post intervention
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
Measured: at 6 months
Change of fecal and blood markers from baseline
Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation
Measured: whole study period
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)
Measured: at 6 and 12 months post intervention
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)
Measured: at 6 and 12 months post intervention
Change of RBDSQ from baseline
REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention.
Measured: 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)
Measured: at 6 and 12 months post intervention
Change of IBS-SSS from baseline
The irritable bowel severity scoring system will be determined at baseline and follow-up
Measured: at 6 and 12 months after intervention
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)
Measured: at 6 and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start25 Apr 2021
- Primary completion27 Dec 2022
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Tampere University Hospital, University of Helsinki, Central Hospital of Paijat-Hame, University of Aarhus
- Responsible party
- Principal investigator, Filip Scheperjans, Helsinki University Central Hospital
- Investigators
- Filip Scheperjans, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854291
- Sponsor's protocol ID
- PD-FMT
- Status last verified
- Oct 2024
- First submitted
- 13 Apr 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Scheperjans F, Levo R, Bosch B, Laaperi M, Pereira PAB, Smolander OP, Aho VTE, Vetkas N, Toivio L, Kainulainen V, Fedorova TD, Lahtinen P, Ortiz R, Kaasinen V, Satokari R, Arkkila P. Fecal Microbiota Transplantation for Treatment of Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):925-938. doi: 10.1001/jamaneurol.2024.2305.
PubMed 39073834
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04854291
- Acronym / sponsor ID
- PD-FMT
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, FMT, microbiota, gut-brain axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Tampere University Hospital, University of Helsinki, Central Hospital of Paijat-Hame, University of Aarhus
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor FMT | Experimental | Other: Administration of donor FMTFMT from a healthy donor |
| Placebo | Placebo comparator | Other: Administration of placeboNaCl + glycerol mixture (carrier solution of FMT arm) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic PD (Clinically Probable PD)
- H\&Y OFF 1-3 at Baseline Visit
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of donor FMTIntracaecal infusion of FMT | Other | Donor FMT |
| Administration of placeboIntracaecal infusion of carrier solution | Other | Placebo |
Primary outcome
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)
13 secondary outcomes
Change of MDS-UPDRS III from baseline
Time frame: at 6 and 12 months post intervention
Change of MDS-UPDRS IV from baseline
Time frame: at 6 and 12 months post intervention
Change of Timed UP GO test from baseline
Time frame: at 6 and 12 months post intervention
Change of MDS-UPDRS I from baseline
Time frame: at 6 and 12 months post intervention
Change of NMSS from baseline
Time frame: at 6 and 12 months post intervention
Change in gut permeability, motility and volume from baseline
Time frame: at 6 months
Change of fecal and blood markers from baseline
Time frame: whole study period
Change of BDI-II from baseline
Time frame: at 6 and 12 months post intervention
Change of BAI from baseline
Time frame: at 6 and 12 months post intervention
Change of RBDSQ from baseline
Time frame: at 6 and 12 months after intervention
Change of MoCa from baseline
Time frame: at 6 and 12 months post intervention
Change of IBS-SSS from baseline
Time frame: at 6 and 12 months after intervention
Change of PDQ39 index from baseline
Time frame: at 6 and 12 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Results publication: PubMed 39073834Scheperjans F, Levo R, Bosch B, Laaperi M, Pereira PAB, Smolander OP, Aho VTE, Vetkas N, Toivio L, Kainulainen V, Fedorova TD, Lahtinen P, Ortiz R, Kaasinen V, Satokari R, Arkkila P. Fecal Microbiota Transplantation for Treatment of Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):925-938. doi: 10.1001/jamaneurol.2024.2305.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Scheperjans, MD principal investigator
Helsinki University Central Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of donor FMT in people with Parkinson Disease, run by Helsinki University Central Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the sum of MDS-UPDRS I-III from baseline (time frame: at 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.