Parkinson's disease
Conditions
Interventions
FMT, with vancomycin and bowel lavage as pre-treatment and domperidone prior to
FMT.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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(
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed