Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

Study Overview
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Brief Summary
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The aim of the study is to assess impact of Fecal Microbiota Transfer (FMT) on clinical symptoms of Parkinson's disease. Assesment of tremor, slowness of movements and balance problems before and after FMT will be performed. The effect of FMT on frequency of constipations, which are common among Parkinson disease patients and have negative impact on quality of life and drug absorption will also be assessed. Detailed assessment of absorption of levodopa, which is the golden standard of treatment of Parkinson disease, is planned. It is planned to recruit 40 patients with diagnosis of Parkinson disease and indications for colonoscopy (constipations, age >50 years). Patients will be randomly assigned to the group receiving treatment with FMT or identically looking placebo. It will be administered to intestine during colonoscopy. Patients will be assessed by neurologist few times after the procedure. Psychological assessment and examination of gait and balance by physiotherapist is also planned. The last assessment will be performed after 12 months to see if the clinical effect can be observed for such a long time. The composition of the intestinal microbiota will be carefully assessed before and after the procedure in order to identify pathogens that may affect the course of the disease.

Official Title
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Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Biological: Fecal Microbiota Transfer provided by Human Biome Institute


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic PD Consent to undergo colonoscopy Exclusion Criteria: perforation or obstruction of gastroenteric tract, radiotherapy of abdomen or pelvis region severe heart, liver or kidney failure coagulation disorders immunity disorders current viral, bacterial or fungal infection abdominal aortic aneurysm qualifying for surgery, pregnancy and lactation treatment with Duodopa, deep brain stimulation or apomorphine colonoscopy confirmed colon polyps, except for lesions <5 mm qualified for the NBI International Colorectal Endoscopic I group or other potentially neoplastic lesions after evaluation in white light and narrow beam imaging (NBI) severe food allergy with a history of anaphylaxis after consumption of the product.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fecal microbiota transplant<br>Pretreatment with rifaximin 3x 400 mg PO for 7 days Fecal Microbiota Transfer from healthy donor during colonoscopy. Assessments in clinical scales: 30 days, 90 days and 12 months: Unified Parkinson Disease Rating Scale, Constipation Assessment Scale, Parkinson Disease Questionnaire-39, Non- Motor Symptoms Questionnaire, Gastrointestinal Dysfunction Scale for Parkinson Disease. Assessment of levodopa/benserazide 200+50 mg tablet before and 30 days after intervention: 20,40, 60, 90, 120, 150, 180 and 240 min since intervention | Biological: Fecal Microbiota Transfer provided by Human Biome Institute<br>* Fecal Microbiota Transfer with colonoscopy<br>* Other names: Assessment in clinical scales;|
| Placebo Comparator: Autotransplant of patients microbiota<br>Pretreatment with rifaximin 3x 400 mg PO for 7 days Autotransplant of patients own microbiota collected in screening period during colonoscopy. Assessments in clinical scales: 30 days, 90 days and 12 months: Unified Parkinson Disease Rating Scale, Constipation Assessment Scale, Parkinson Disease Questionnaire-39, Non- Motor Symptoms Questionnaire, Gastrointestinal Dysfunction Scale for Parkinson Disease. Assessment of levodopa/benserazide 200+50 mg tablet before and 30 days after intervention: 20,40, 60, 90, 120, 150, 180 and 240 min since intervention | Biological: Fecal Microbiota Transfer provided by Human Biome Institute<br>* Fecal Microbiota Transfer with colonoscopy<br>* Other names: Assessment in clinical scales;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in progression of motor symptoms of Parkinson Diseae | Reduction or no change in Unified Parkinson Disease Rating Scale part III (motor) in off state (min. 0, max 108 points) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bowel movements | Change of score in Gastrointestinal Dysfunction Scale for Parkinson Disease ( a minimum score of 1 and a maximum score of 108) | 12 months | 
| Change in bowel movements | Change of score in Constipation Assessment Scale (a minimum score of 0 and a maximum score of 16) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiota Transplant