RESUMO
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.
Assuntos
Transplante de Microbiota Fecal , Doença de Parkinson , Humanos , Estudos de Viabilidade , Transplante de Microbiota Fecal/efeitos adversos , Transplante de Microbiota Fecal/métodos , Fezes , Levodopa , Doença de Parkinson/terapia , Doença de Parkinson/etiologia , Projetos Piloto , Estudos Prospectivos , Resultado do TratamentoRESUMO
Here, we describe the epidemiology, diagnostics, and treatment of Clostridioides difficile infection (CDI) in the primary health care setting. CDI is traditionally considered as a healthcare associated infection. However, infections with onset in the community represent a large proportion of CDI. Traditional CDI risk factors apply to the population encountered in general practice: age ≥50 years, malignancy or other underlying disease, hospital admission and/or antibiotic treatment in the past 3 months. Notably, about a third has had no recent antibiotic exposure nor has been admitted to a hospital. Based on diagnostic tests requested by the general practitioner, only half of CDI cases will be diagnosed. In this setting, it is advisable to request a diagnostic C. difficile test for patients with persisting or severe diarrhea and negative tests for traditional enteropathogens (Salmonella, Shigella, Yersinia, Campylobacter), also in the absence of traditional risk factors for CDI.
Assuntos
Clostridioides difficile , Infecções por Clostridium , Infecção Hospitalar , Humanos , Pessoa de Meia-Idade , Antibacterianos/uso terapêutico , Infecções por Clostridium/diagnóstico , Infecções por Clostridium/tratamento farmacológico , Infecções por Clostridium/epidemiologia , HospitalizaçãoRESUMO
We report a patient with a 5-year diagnosis of akinetic-rigid Parkinson's disease under treatment with Levodopa-Carbidopa Intestinal Gel therapy through a PEG-J tube due to motor complications, in which, in the context of a clinical study, we successfully and safely administered fecal microbiota transplant through a PEG-J.