Parkinson DiseaseNCT03808389
Fecal Microbiota Transplantation for Parkinson's Disease
A study testing Donor FMT and Autologous FMT in people with Parkinson Disease, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Donor FMT and Autologous FMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2020to 9 Dec 2022
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Clinical PD diagnosis (MDS criteria)
- Hoehn \& Yahr score of 2-3 in OFF
- Age of motor symptoms onset > 50 years
- age 18 - 75 years
- signed informed consent
- normal screening protocol, including screening for infectious diseases, according to the recommendations of the Superior Health Council of Belgium concerning the safety and quality of fecal transplantation in humans
Who cannot join
- 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)
Show all 23Show fewer
- 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
- presence of gastrointestinal symptoms
- gastro-intestinal or other important comorbidity
- obesity or metabolic syndrome
- history of malignancy both gastrointestinal or systemic
- presence of known colon polyps
- recent placing of piercings/tattoos
- sexual risk behaviour
- antimicrobial therapy 3 months prior to donation
- living in the same household as a Parkinson's disease patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Clinical Trial Investigating Fecal Microbiota Transplantation for Parkinson's Disease and Its Effect on Symptoms and Disease Progression
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.
Read the detailed description
In this study the effects of fecal microbiota transplantation (FMT) on patients with Parkinson's disease will be investigated in a double-blind, placebo-controlled randomized clinical trial.
At time of FMT, forty patients will be randomized in a double-blinded fashion to the treatment arm (healthy donor stool) or placebo arm (own stool). Transplantation will be performed through nasojejunal administration.
Donors for this study will be recruited from a healthy donor pool who will donate stool after clearance of a strict inclusion protocol which will assess the presence of any infectious diseases. Donor stool will be frozen and stored until day of FMT.
Participants will be screened for relevant inclusion and exclusion criteria and will have to sign an informed consent before admission to the study.
Prior and on a regular basis following the FMT participants will be evaluated through neurological clinical examination and standardized clinical scoring scales including MDS-UPDRS, PDQ-39, NMSS and MoCA. Stool samples will be taken regularly and stored at -80°C for microbiome analysis. Blood will be collected for determining relevant markers. All participants will also undergo sampling for oral and nasal microbiome. Follow-up will continue for a total duration of one year.
Prior to FMT, all participants will undergo a colonoscopy to exclude contra-indications for FMT and to collect mucosa-adherent microbial samples and gastrointestinal tissue biopts. This colonoscopy will be repeated once, one year following the FMT.
The primary endpoint in this study will be a change in clinical status measured through the MDS-UPDRS. Additionally, motor and non-motor symptoms will be correlated with serum markers of inflammation and gut and central nervous system barrier function, microbiota changes and gastrointestinal biopsy analysis of inflammation.
- Conditions
- Parkinson Disease
- Being tested
- Donor FMT, Autologous FMT
- Keywords
- Parkinson's disease, Fecal microbiota transplantation, Microbiome, 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.
Donor FMTOther
Also called FMT with donor stool
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.
Autologous FMTOther
Also called FMT with own stool
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Donor FMT |
| Control group: Autologous FMT | Sham comparator | Fecal microbiota transplantation using the patient's own fecal matter. Receives: Other: Autologous FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Goetz, C. et al. Movement Disord 22, 41-47 (2007).
- Goetz, C. et al. Movement Disord 23, 2129-2170 (2008).
Measured: 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)
Non-motor symptoms scale for Parkinson's disease (NMSS). Non-motor symptoms are assessed over the last month. Each symptom is scored with respect to:
Severity: 0 = None; 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.
Frequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).
NMSS contains nine dimensions: cardiovascular (2 items), sleep/fatigue (4 items), mood/cognition (6 items), perceptual problems (3 items), attention/memory (3 items), gastrointestinal (3 items), urinary (3 items), sexual function (2 items), and miscellaneous (4 items).
Subscores are calculated through multiplication of frequency x severity. Total score is calculated by adding all subscores, range 0-360.
Reference: Chaudhuri, K. R. et al. Mov. Disord. 22, 1901-11 (2007).
Measured: 3 months, 6 months, 12 months
Changes in quality of life as scored on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Parkinson's Disease Quality of Life Questionnaire. All 39 questions are coded in the same way: 0 = Never; 1 = Occasionally; 2 = Sometimes; 3 = Often; 4 = Always (or cannot do at all, if applicable).
The different dimensions are mobility (10 items), activities of daily living (6 items), emotional well being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items).
Each dimension is calculated as a scale from 0 to 100 (0 = no problem at all; 100 = maximum level of problem). Formula for scoring each dimension = (sum of scores of each question in dimension)/ (4 x number of questions in dimension) x 100.
The Single Index score: PDQ-SI= summing the eight dimensions and then dividing by eight.
Reference: Jenkinson, C., Fitzpatrick, R., Peto, V., Greenhall, R. \& Hyman, N. Age Ageing 26, 353-7 (1997).
Measured: 3 months, 6 months, 12 months
Changes in cognition as scored on the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) assesses several cognitive domains: short-term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, orientation to time and place. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Reference: Nasreddine, Z. et al. J Am Geriatr Soc 53, 695-699 (2005).
Measured: 3 months, 6 months, 12 months
Number of participants with a change in required anti-PD symptomatic or levodopa therapy
Measured: 3 months, 6 months, 12 months
Changes in gastrointestinal symptoms as assessed by the Rome IV questionnaire
The Rome IV criteria for functional constipation and irritable bowel syndrome are assessed to evaluate potential change in gastrointestinal symptoms following the fecal microbiota transplantation.
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Dec 2020
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
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 University GhentThe 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
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, the Flanders Institute for Biotechnology, Research Foundation Flanders, Vlaamse Parkinson Liga, Parkili
- Responsible party
- Sponsor
- Investigators
- Patrick Santens, MD, PhD, Principal investigator, Ghent University, Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808389
- Sponsor's protocol ID
- UGent2018/0623
- Status last verified
- Jan 2023
- First submitted
- 22 Jun 2018
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38686220
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Clinical Trial Investigating Fecal Microbiota Transplantation for Parkinson's Disease and Its Effect on Symptoms and Disease Progression
- ClinicalTrials.gov ID
- NCT03808389
- Acronym / sponsor ID
- UGent2018/0623
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Fecal microbiota transplantation, Microbiome, Gut-brain axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, the Flanders Institute for Biotechnology, Research Foundation Flanders, Vlaamse Parkinson Liga, Parkili
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 17 Jan 2019 (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.
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.
Detailed description
In this study the effects of fecal microbiota transplantation (FMT) on patients with Parkinson's disease will be investigated in a double-blind, placebo-controlled randomized clinical trial.
At time of FMT, forty patients will be randomized in a double-blinded fashion to the treatment arm (healthy donor stool) or placebo arm (own stool). Transplantation will be performed through nasojejunal administration.
Donors for this study will be recruited from a healthy donor pool who will donate stool after clearance of a strict inclusion protocol which will assess the presence of any infectious diseases. Donor stool will be frozen and stored until day of FMT.
Participants will be screened for relevant inclusion and exclusion criteria and will have to sign an informed consent before admission to the study.
Prior and on a regular basis following the FMT participants will be evaluated through neurological clinical examination and standardized clinical scoring scales including MDS-UPDRS, PDQ-39, NMSS and MoCA. Stool samples will be taken regularly and stored at -80°C for microbiome analysis. Blood will be collected for determining relevant markers. All participants will also undergo sampling for oral and nasal microbiome. Follow-up will continue for a total duration of one year.
Prior to FMT, all participants will undergo a colonoscopy to exclude contra-indications for FMT and to collect mucosa-adherent microbial samples and gastrointestinal tissue biopts. This colonoscopy will be repeated once, one year following the FMT.
The primary endpoint in this study will be a change in clinical status measured through the MDS-UPDRS. Additionally, motor and non-motor symptoms will be correlated with serum markers of inflammation and gut and central nervous system barrier function, microbiota changes and gastrointestinal biopsy analysis of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment group: Donor FMT | Experimental | Other: Donor FMTFecal microbiota transplantation using fecal matter from a healthy donor selected through strict inclusion criteria assessing the presence of any infectious diseases. |
| Control group: Autologous FMT | Sham comparator | Other: Autologous FMTFecal microbiota transplantation using the patient's own fecal matter. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent.
- Clinical PD diagnosis (MDS criteria)
- Hoehn \& Yahr score of 2-3 in OFF
- Age of motor symptoms onset > 50 years
- age 18 - 75 years
Key exclusion criteria (23 listed)
- 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)
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 |
|---|---|---|
| Donor FMTAlso: FMT with donor stoolFecal 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 | Treatment group: Donor FMT |
| Autologous FMTAlso: FMT with own stoolFecal 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. | Other | Control group: Autologous FMT |
Primary outcome
Changes in clinical symptoms as scored on the MDS-UPDRS (Movement Disorder Society - Unified Parkinson's Disease Rating Scale)
Time frame: 3 months, 6 months, 12 months
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).
5 secondary outcomes
Changes in non-motors symptoms as scored on the Non-motor symptoms scale for Parkinson's disease (NMSS)
Time frame: 3 months, 6 months, 12 months
Changes in quality of life as scored on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time frame: 3 months, 6 months, 12 months
Changes in cognition as scored on the Montreal Cognitive Assessment (MoCA)
Time frame: 3 months, 6 months, 12 months
Number of participants with a change in required anti-PD symptomatic or levodopa therapy
Time frame: 3 months, 6 months, 12 months
Changes in gastrointestinal symptoms as assessed by the Rome IV questionnaire
Time frame: 3 months, 6 months, 12 months
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 30 Jan 2023.
- Derived from this study: PubMed 38686220Bruggeman 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.
- Individual participant dataSharing planned: No
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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.
Patrick Santens, MD, PhD principal investigator
Ghent University, Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donor FMT and Autologous FMT in people with Parkinson Disease, run by University Ghent at 1 site in Belgium.
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 7 inclusion and 23 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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Changes in clinical symptoms as scored on the MDS-UPDRS (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) (time frame: 3 months, 6 months, 12 months). 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 NCT03808389, 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 30 Jan 2023.