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

Parkinson Disease Clinical Trial

Official title: Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05204641
• Study type: Interventional
• Source: Medical University of Warsaw
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Completion date: December 31, 2024