Influence of intestinal microbiota transfer on the clinical course of Parkinson's disease

Project Title
Wpływ transferu mikrobioty jelitowej na przebieg kliniczny choroby Parkinsona
Financing Institution
Lead
dr hab. Dariusz Koziorowski
Project Objective

The aim of the study is to evaluate the effect of intestinal microbiota transfer (TMJ) in patients with Parkinson's disease (PD) on the severity of motor and extra-motor symptoms and disease progression in a 12-month follow-up. 40 patients with reliable diagnosis of PD with indications for colonoscopy will be recruited for the study. Before the study, patients will be randomized 1: 1 to the group treated with TMJ - MBiotix HBI or the group receiving placebo (a preparation made from previously collected feces). The TMJ procedure will be performed during the colonoscopy and the preparation will be administered enterally. In the remaining patients, a properly prepared placebo preparation will be administered. Both the patients and the neurologist will be blind to the intervention performed during the colonoscopy. All patients before the procedure and at specific time points after the procedure (1, 3, 12 months) will be assessed by a neurologist. Patients will be assessed on the scales of severity of motor symptoms (UPDRS) and non-motor PD. The last evaluation will be made 12 months after the procedure. Before the procedure, and also 3 months after the procedure, the composition of the intestinal microbiota will be tested. The composition of microbiota in preparations intended for transplantation for patients will also be examined. In addition, before the procedure and 3 months after the procedure, patients will be tested to assess the pharmacokinetics of the absorption of 125 mg of levodopa with benserazide. Before and 12 months after surgery, a psychological and posturographic assessment is planned.