Cargando…
Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study
INTRODUCTION: Experimental studies suggest a role of gut microbiota in the pathophysiology of Parkinson’s disease (PD) via the gut–brain axis. The gut microbiota can also influence the metabolism of levodopa, which is the mainstay of treatment of PD. Therefore, modifying the gut microbiota by faecal...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10565159/ https://www.ncbi.nlm.nih.gov/pubmed/37798034 http://dx.doi.org/10.1136/bmjopen-2023-071766 |
_version_ | 1785118639837413376 |
---|---|
author | Vendrik, Karuna EW Chernova, Vlada O Kuijper, Ed J Terveer, Elisabeth M van Hilten, Jacobus J Contarino, Maria Fiorella |
author_facet | Vendrik, Karuna EW Chernova, Vlada O Kuijper, Ed J Terveer, Elisabeth M van Hilten, Jacobus J Contarino, Maria Fiorella |
author_sort | Vendrik, Karuna EW |
collection | PubMed |
description | INTRODUCTION: Experimental studies suggest a role of gut microbiota in the pathophysiology of Parkinson’s disease (PD) via the gut–brain axis. The gut microbiota can also influence the metabolism of levodopa, which is the mainstay of treatment of PD. Therefore, modifying the gut microbiota by faecal microbiota transplantation (FMT) could be a supportive treatment strategy. METHODS AND ANALYSIS: We have developed a study protocol for a single-centre, prospective, self-controlled, interventional, safety and feasibility donor-FMT pilot study with randomisation and double-blinded allocation of donor faeces. The primary objectives are feasibility and safety of FMT in patients with PD. Secondary objectives include exploring whether FMT leads to alterations in motor complications (fluctuations and dyskinesias) and PD motor and non-motor symptoms (including constipation), determining alterations in gut microbiota composition, assessing donor–recipient microbiota similarities and their association with PD symptoms and motor complications, evaluating the ease of the study protocol and examining FMT-related adverse events in patients with PD. The study population will consist of 16 patients with idiopathic PD that use levodopa and experience motor complications. They will receive FMT with faeces from one of two selected healthy human donors. FMT will be administered via a gastroscope into the duodenum, after treatment with oral vancomycin, bowel lavage and domperidone. There will be seven follow-up moments during 12 months. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethical Committee Leiden Den Haag Delft (ref. P20.087). Study results will be disseminated through publication in peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER: International Clinical Trial Registry Platform: NL9438. |
format | Online Article Text |
id | pubmed-10565159 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-105651592023-10-12 Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study Vendrik, Karuna EW Chernova, Vlada O Kuijper, Ed J Terveer, Elisabeth M van Hilten, Jacobus J Contarino, Maria Fiorella BMJ Open Neurology INTRODUCTION: Experimental studies suggest a role of gut microbiota in the pathophysiology of Parkinson’s disease (PD) via the gut–brain axis. The gut microbiota can also influence the metabolism of levodopa, which is the mainstay of treatment of PD. Therefore, modifying the gut microbiota by faecal microbiota transplantation (FMT) could be a supportive treatment strategy. METHODS AND ANALYSIS: We have developed a study protocol for a single-centre, prospective, self-controlled, interventional, safety and feasibility donor-FMT pilot study with randomisation and double-blinded allocation of donor faeces. The primary objectives are feasibility and safety of FMT in patients with PD. Secondary objectives include exploring whether FMT leads to alterations in motor complications (fluctuations and dyskinesias) and PD motor and non-motor symptoms (including constipation), determining alterations in gut microbiota composition, assessing donor–recipient microbiota similarities and their association with PD symptoms and motor complications, evaluating the ease of the study protocol and examining FMT-related adverse events in patients with PD. The study population will consist of 16 patients with idiopathic PD that use levodopa and experience motor complications. They will receive FMT with faeces from one of two selected healthy human donors. FMT will be administered via a gastroscope into the duodenum, after treatment with oral vancomycin, bowel lavage and domperidone. There will be seven follow-up moments during 12 months. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethical Committee Leiden Den Haag Delft (ref. P20.087). Study results will be disseminated through publication in peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER: International Clinical Trial Registry Platform: NL9438. BMJ Publishing Group 2023-10-05 /pmc/articles/PMC10565159/ /pubmed/37798034 http://dx.doi.org/10.1136/bmjopen-2023-071766 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Neurology Vendrik, Karuna EW Chernova, Vlada O Kuijper, Ed J Terveer, Elisabeth M van Hilten, Jacobus J Contarino, Maria Fiorella Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study |
title | Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study |
title_full | Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study |
title_fullStr | Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study |
title_full_unstemmed | Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study |
title_short | Safety and feasibility of faecal microbiota transplantation for patients with Parkinson’s disease: a protocol for a self-controlled interventional donor-FMT pilot study |
title_sort | safety and feasibility of faecal microbiota transplantation for patients with parkinson’s disease: a protocol for a self-controlled interventional donor-fmt pilot study |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10565159/ https://www.ncbi.nlm.nih.gov/pubmed/37798034 http://dx.doi.org/10.1136/bmjopen-2023-071766 |
work_keys_str_mv | AT vendrikkarunaew safetyandfeasibilityoffaecalmicrobiotatransplantationforpatientswithparkinsonsdiseaseaprotocolforaselfcontrolledinterventionaldonorfmtpilotstudy AT chernovavladao safetyandfeasibilityoffaecalmicrobiotatransplantationforpatientswithparkinsonsdiseaseaprotocolforaselfcontrolledinterventionaldonorfmtpilotstudy AT kuijperedj safetyandfeasibilityoffaecalmicrobiotatransplantationforpatientswithparkinsonsdiseaseaprotocolforaselfcontrolledinterventionaldonorfmtpilotstudy AT terveerelisabethm safetyandfeasibilityoffaecalmicrobiotatransplantationforpatientswithparkinsonsdiseaseaprotocolforaselfcontrolledinterventionaldonorfmtpilotstudy AT vanhiltenjacobusj safetyandfeasibilityoffaecalmicrobiotatransplantationforpatientswithparkinsonsdiseaseaprotocolforaselfcontrolledinterventionaldonorfmtpilotstudy AT contarinomariafiorella safetyandfeasibilityoffaecalmicrobiotatransplantationforpatientswithparkinsonsdiseaseaprotocolforaselfcontrolledinterventionaldonorfmtpilotstudy AT safetyandfeasibilityoffaecalmicrobiotatransplantationforpatientswithparkinsonsdiseaseaprotocolforaselfcontrolledinterventionaldonorfmtpilotstudy |