Parkinson Disease
Conditions
Brief 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.
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: 1. PD patients that will not receive FMT 2. healthy people who live with PD patients in the same house and share similar surrounding
Interventions
PROCEDUREfecal microbial transplantation
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.
Sponsors
Soroka University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| motor parkinsonian symptoms | Change from baseline motor difficulties at 6 months | motor symptoms assessed by UPDRS III questionaire |
| constipation level | 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). |
Countries
Israel
Outcome results
None listed