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Therapeutic Evaluation of Fecal Microbiota Transplantation in an Interleukin 10-Deficient Mouse Model
Published on: April 6, 2022
Safety and feasibility of faecal microbiota transplantation for patients with Parkinson's disease: a protocol for a
Karuna Ew Vendrik1, Vlada O Chernova2,3, Ed J Kuijper2
1Department of Medical Microbiology, Centre for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands karunavendrik@gmail.com.
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.
Insights
This pilot study investigates the safety and feasibility of fecal microbiota transplantation (FMT) for Parkinson's disease (PD) patients. FMT may offer a supportive strategy by modulating gut microbiota and potentially improving motor symptoms.
Area of Science:
- Neuroscience
- Gastroenterology
- Microbiology
Background:
- Gut microbiota alterations are implicated in Parkinson's disease (PD) pathophysiology via the gut-brain axis.
- Gut microbiota influences levodopa metabolism, the primary PD treatment.
- Faecal microbiota transplantation (FMT) presents a potential supportive therapeutic strategy for PD.
Purpose of the Study:
- To assess the feasibility and safety of donor-FMT in patients with idiopathic Parkinson's disease.
- To explore FMT's effects on motor complications (fluctuations, dyskinesias) and non-motor symptoms (e.g., constipation).
- To analyze changes in gut microbiota composition and its association with PD symptoms.
Main Methods:
- A single-centre, prospective, self-controlled, interventional pilot study.
- 16 idiopathic PD patients receiving FMT from two healthy donors after vancomycin and bowel lavage.
- Duodenal FMT administration with seven follow-up points over 12 months.
Main Results:
- Primary outcomes focus on feasibility and safety of the FMT procedure.
- Secondary outcomes include changes in motor and non-motor PD symptoms and gut microbiota composition.
- Exploration of donor-recipient microbiota similarity and its correlation with symptom changes.
Conclusions:
- FMT is being investigated as a novel approach for Parkinson's disease management.
- The study protocol aims to establish safety and feasibility for future larger trials.
- Understanding gut microbiota modulation may lead to improved therapeutic strategies for PD.
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