Recruiting · registry statusA pilot study of donor gut microbes
Researchers are investigating the practicality of transferring gut microbes to people with Parkinson's after preparatory treatment.
Testing a treatment or activity · Study reference: NL-OMON52432
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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Results reported
- Start (reported date)
- 2021-12-14
- Study finished (reported date)
- 2024-06-11
Planned dates can move. A study finishing does not tell us when a paper will be published.
Read the results reported in the registry
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 18 to 99 · Ask the team who can join
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: Not reported
Inclusion criteria: - Clinical diagnosis of idiopathic PD according to UK Brain Bank criteria
- PD disease duration of at least five years.
- Use of levodopa.
- Presence of motor complications (motor fluctuations or dyskinesias), despite
adequate PD medication and regardless of severity.
- Written informed consent.
Exclusion criteria: - Hoehn and Yahr scale stage 5 (most severe stage in scale for severity of PD
motor symptoms).
- Comorbidity or condition impairing ability to participate in the study
according to the investigators.
- Current use of probiotics or in the previous three months.
- Unstable PD with change in type or dose of PD medication in the previous
three months.
- Symptoms of a GI infection during the previous three months.
- Current need of antibiotics or use in the previous three months.
- Current GI malignancy or in the previous six months.
- Known obstructions, paralysis or severe motility problems of the
gastrointestinal tract, or severe dysphagia with incapability of swallowing 2
liters of macrogol + electrolytes, or inability to receive oral feeding.
- Known diagnosis of Inflammatory Bowel Disease (IBD) or celiac disease.
- Intestinal resection in medical history.
- Recent intraabdominal surgery(< 3 months).
- Platelet count < 70x10^9/L
- Participation in another study within 16 weeks of screening visit.
- Known severe food allergy or allergy to medication that a donor could have
used (intake may lead to a life threatening situation).
- Immunocompromised state.
- Current use of immunosuppressants or opiates, or in the previous month.
- For women with child-bearing potential: Pregnancy; current wish to be
pregnant or absence of contraception; lactation.
- Impaired ability to understand the study content and to give written informed
consent.
- Unwilling or not capable to comply with the study requirements.
- Inability to communicate in Dutch.
- Inability to visit the LUMC.
Full study name & original research details
Official study title
Fecal Microbiota Transplantation for Parkinson*s Disease: a pilot study - FMT4PD
Short title used by the registry
Fecal Microbiota Transplantation for Parkinson*s Disease: a pilot study
Original description
Intervention:
FMT, with vancomycin and bowel lavage as pre-treatment and domperidone prior to
FMT.
Primary outcome:
Main study endpoints:
1. Feasibility of FMT in PD patients: the number of included patients that
cannot undergo FMT due to a patient- or procedure-related reason.
2. Safety of FMT in PD patients: FMT-related serious adverse events (SAEs)
Secondary outcome:
1. Alterations in gut microbiota structure (16S rRNA gene amplicon sequencing)
after FMT, with comparison to the donor gut microbiota, and how these associate
with PD symptoms and motor complications.
2. Changes after FMT (as compared to the change observed after one-week
standard-of-care observation) and differences between patient groups based on
the selected donors on the following aspects:
• Severity of motor complications, i.e. number and duration of off periods and
periods with troublesome dyskinesias per day (3 days diary)
• MDS-UPDRS (on medication)
• Required PD medication dose
• Hoehn and Yahr score
• Q10 questionnaire (wearing off)
• Montreal Cognitive Assessment (MOCA)
• Severity of GI symptoms and defecation frequency
• Bristol stool scale
• Other non-motor symptoms (SEverity of Non-dopaminergic Symptoms in
Parkinson*s Disease (SENS-PD) scale)
3. Ease of the study protocol, assessed by the reasons for refrainment of
participation in the
study after receiving full information at V1, and study load for participants,
assessed bij 0-10 scale and open questions.
4. FMT-related AEs in PD patients after FMT, assessed by the registration of
FMT-related AEs.
Conditions reported: Parkinson's disease; Parkinson disease;10028037
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- FMT, with vancomycin and bowel lavage as pre-treatment and domperidone prior to
FMT.
- Phases
- 2
- Sponsor
- Leids Universitair Medisch Centrum
- Start date reported by registry
- 2021-12-14 (reported)
Registry updated: Not reported · Status last verified by the registry submitter: Not reported
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Facility not reported
Netherlands
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.