Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease (EFFACE-PD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Biological: Fecal Microbiota Transfer provided by Human Biome Institute

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 03-242
    • Department of Neurology, Faculty of health sciences, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fecal microbiota transplant; 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; Fecal Microbiota Transfer with colonoscopy; Other Names: Pretreatment with rifaximin 3x 400 mg PO for 7 days; Assessment of levodopa/benserazide 100+25 mg tablet absorption before and 90 days after intervention: 20,40, 60, 90, 120, 150, 180 and 240 min since intervention- Area under the curve (AUC), Cmax; Assessment in clinical scales
Placebo Comparator: Autotransplant of patients microbiota; 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; Fecal Microbiota Transfer with colonoscopy; Other Names: Pretreatment with rifaximin 3x 400 mg PO for 7 days; Assessment of levodopa/benserazide 100+25 mg tablet absorption before and 90 days after intervention: 20,40, 60, 90, 120, 150, 180 and 240 min since intervention- Area under the curve (AUC), Cmax; Assessment in clinical scales

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of levodopa bioavailability	Change in levodopa-carbidopa concentration in peripheral blood (AUC)	3 months

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Human Biome Institute S.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): October 28, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplant
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Rifaximin; Levodopa; Benserazide
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No