Parkinson DiseasePhase 2/3NCT03876327
Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease
A Phase 2/3 study testing fecal microbial transplantation in people with Parkinson Disease, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
this pilot study aims to further explore the potential usage of Fecal microbiota transplantation in treating constipation and possibly also motor symptoms in Parkinson's disease (PD) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and PD. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- fecal microbial transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Aug 2015to 30 Jun 2020
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged > 50 years, diagnosed as suffering from PD and under follow up of the Movement Disorders Clinic in Soroka University Medical Center.
- Subjects complaining of constipation .
- Subjects who did not perform a screening colonoscopy for colon cancer.
- Subjects who are clinically undertreated according to last Movement Disorders specialist's impression at the clinic visit.
Who cannot join
- Subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically.
- Subjects who already underwent a screening colonoscopy for colon cancer.
- Subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study
this pilot study aims to further explore the potential usage of Fecal microbiota transplantation in treating constipation and possibly also motor symptoms in Parkinson's disease (PD) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and PD.
Read the detailed description
Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms and Gastrointestinal dysfunction, in particular constipation, affects up to 80% of PD patients and may precede the onset of motor symptoms by years.
this study include one group of PD patients that will receive FMT. two other groups will serve as controls:
- PD patients that will not receive FMT
- healthy people who live with PD patients in the same house and share similar surrounding
- Conditions
- Parkinson Disease
- Being tested
- fecal microbial transplantation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbial transplantationProcedure or surgery
Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.
| Study group | Role | What they receive |
|---|---|---|
| PD patients that will receive FMT | Experimental | fecal microbial transplantation once at the beginning of the study-15 patients. Receives: Procedure: fecal microbial transplantation |
| PD patients that will not receive FMT | No intervention | do not receive treatment-35 patients. |
| healthy people live with PD patients | No intervention | do not receive treatment-50 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor parkinsonian symptoms
motor symptoms assessed by UPDRS III questionaire
Measured: Change from baseline motor difficulties at 6 months
constipation level
constipation will be assessed by a scoring system questionaire. 6 parameters are reviewed as scored fro 0 (mild symptom) to 4 (srvere symptom).
Measured: Change from baseline constipation level at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start19 Aug 2015
- Primary completion30 Dec 2019
- Study completion30 Jun 2020
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups were included in the study: 1. PD patients that will undergo FMT tretment and a half of year follow-up-15 patients. 2. PD patients that will not undergo FMT procedure and will donate stool sample only once-35 patients. 3. healthy PD relatives, that live with them and have similiar life styling and which will donate stool sample only once-50 participants.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARIK SEGAL MD, Soroka University Medical Center
- Investigators
- arik segal, MD, Principal investigator, SOROKA MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876327
- Sponsor's protocol ID
- 0266-15-SOR
- Status last verified
- Aug 2020
- First submitted
- 20 Feb 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Segal A, Zlotnik Y, Moyal-Atias K, Abuhasira R, Ifergane G. Fecal microbiota transplant as a potential treatment for Parkinson's disease - A case series. Clin Neurol Neurosurg. 2021 Aug;207:106791. doi: 10.1016/j.clineuro.2021.106791. Epub 2021 Jun 30.
PubMed 34237681
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT03876327
- Acronym / sponsor ID
- 0266-15-SOR
- Conditions
- Parkinson Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 19 Aug 2015 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Mar 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.
this pilot study aims to further explore the potential usage of Fecal microbiota transplantation in treating constipation and possibly also motor symptoms in Parkinson's disease (PD) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and PD.
Detailed description
Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms and Gastrointestinal dysfunction, in particular constipation, affects up to 80% of PD patients and may precede the onset of motor symptoms by years.
this study include one group of PD patients that will receive FMT. two other groups will serve as controls:
- PD patients that will not receive FMT
- healthy people who live with PD patients in the same house and share similar surrounding
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups were included in the study: 1. PD patients that will undergo FMT tretment and a half of year follow-up-15 patients. 2. PD patients that will not undergo FMT procedure and will donate stool sample only once-35 patients. 3. healthy PD relatives, that live with them and have similiar life styling and which will donate stool sample only once-50 participants.
| Arm | Type | Receives |
|---|---|---|
| PD patients that will receive FMT | Experimental | Procedure: fecal microbial transplantationfecal microbial transplantation once at the beginning of the study-15 patients. |
| PD patients that will not receive FMT | No intervention | –do not receive treatment-35 patients. |
| healthy people live with PD patients | No intervention | –do not receive treatment-50 participants. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged > 50 years, diagnosed as suffering from PD and under follow up of the Movement Disorders Clinic in Soroka University Medical Center.
- Subjects complaining of constipation .
- Subjects who did not perform a screening colonoscopy for colon cancer.
- Subjects who are clinically undertreated according to last Movement Disorders specialist's impression at the clinic visit.
Key exclusion criteria (3 listed)
- Subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically.
- Subjects who already underwent a screening colonoscopy for colon cancer.
- Subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy.
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 |
|---|---|---|
| fecal microbial transplantationFecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut. | Procedure or surgery | PD patients that will receive FMT |
Primary outcome
motor parkinsonian symptoms
Time frame: Change from baseline motor difficulties at 6 months
motor symptoms assessed by UPDRS III questionaire
constipation level
Time frame: Change from baseline constipation level at 6 months
constipation will be assessed by a scoring system questionaire. 6 parameters are reviewed as scored fro 0 (mild symptom) to 4 (srvere symptom).
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 5 Aug 2020.
- Derived from this study: PubMed 34237681Segal A, Zlotnik Y, Moyal-Atias K, Abuhasira R, Ifergane G. Fecal microbiota transplant as a potential treatment for Parkinson's disease - A case series. Clin Neurol Neurosurg. 2021 Aug;207:106791. doi: 10.1016/j.clineuro.2021.106791. Epub 2021 Jun 30.
- Individual participant dataSharing planned: Undecided
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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.
arik segal, MD principal investigator
SOROKA MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fecal microbial transplantation in people with Parkinson Disease, run by Soroka University Medical Center at 1 site in Israel.
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 4 inclusion and 3 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 5 Aug 2020. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
motor parkinsonian symptoms (time frame: Change from baseline motor difficulties at 6 months). The study lists 2 primary outcomes in all. 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 NCT03876327, 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 5 Aug 2020.