Safety and feasibility of faecal microbiota transplantation for patients with Parkinson's disease: a protocol for a self-controlled interventional donor-FMT pilot study.

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. 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. 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. International Clinical Trial Registry Platform: NL9438.

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Competing interests: Outside this work, MFC received travel support from Boston Scientific, she was in an advisory board of Medtronic (fees to institution), she was an independent consultant for research and/or educational issues (fees to institution) for Medtronic, Boston Scientific, Inbrain, and CHDR, she received speaking fees of Abbvie (CME activity) and ECMT (CME activity), she received research support from Medtronic (unrestricted educational grant to institution), Global Kinetics Corporation (research support in-kind) and Abbvie (grant support to institution). EMT and EJK of the NDFB report an unrestricted research grant of Vedanta Biosciences (https://www.vedantabio.com/), which was not specifically granted for this study. Outside this work, JJvH has received grants from the Alkemade-Keuls Foundation, Stichting Parkinson Fonds, Parkinson Vereniging, The Netherlands Organisation for Health Research and Development, Hersenstichting, AbbVie, Michael J Fox Foundation, and research support from the Centre of Human Drug Research. These funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.