Clinical trial NCT03876327: Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease
Official title: Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: motor parkinsonian symptoms
timeFrame: Change from baseline motor difficulties at 6 months
measure: constipation level
timeFrame: Change from baseline constipation level at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: SOROKA MC
name: arik segal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.