NL-OMON52432招募中2 期
Fecal Microbiota Transplantation for Parkinson*s Disease: a pilot study - FMT4PD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Clinical diagnosis of idiopathic PD according to UK Brain Bank criteria
- •- PD disease duration of at least five years.
- •- Use of levodopa.
- •- Presence of motor complications (motor fluctuations or dyskinesias), despite
- •adequate PD medication and regardless of severity.
- •- Written informed consent.
排除标准
- •- Hoehn and Yahr scale stage 5 (most severe stage in scale for severity of PD
- •motor symptoms).
- •- Comorbidity or condition impairing ability to participate in the study
- •according to the investigators.
- •- Current use of probiotics or in the previous three months.
- •- Unstable PD with change in type or dose of PD medication in the previous
- •three months.
- •- Symptoms of a GI infection during the previous three months.
- •- Current need of antibiotics or use in the previous three months.
- •- Current GI malignancy or in the previous six months.
- •- Known obstructions, paralysis or severe motility problems of the
- •gastrointestinal tract, or severe dysphagia with incapability of swallowing 2
- •liters of macrogol + electrolytes, or inability to receive oral feeding.
- •- Known diagnosis of Inflammatory Bowel Disease (IBD) or celiac disease.
- •- Intestinal resection in medical history.
- •- Recent intraabdominal surgery(< 3 months).
- •- Platelet count < 70x10^9/L
- •- Participation in another study within 16 weeks of screening visit.
- •- Known severe food allergy or allergy to medication that a donor could have
- •used (intake may lead to a life threatening situation).
- •- Immunocompromised state.
- •- Current use of immunosuppressants or opiates, or in the previous month.
- •- For women with child-bearing potential: Pregnancy; current wish to be
- •pregnant or absence of contraception; lactation.
- •- Impaired ability to understand the study content and to give written informed
- •- Unwilling or not capable to comply with the study requirements.
- •- Inability to communicate in Dutch.
- •- Inability to visit the LUMC.
研究者
相似试验
招募中
2 期
Fecal Microbiota Transplantation for Parkinson’s Disease: a pilot study<p>Parkinson's disease</p>Parkinson's disease, Fecal microbiota transplantation10028037NL-OMON25789MC16
招募中
不适用
Fecal microbiota transplantation for neurodegenerative patientsDiseases of the nervous systemKCT0006821Inha University Hospital20
招募中
不适用
Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With ConstipationFecal Microbiota TransplantationParkinson's DiseaseNCT04837313Guangzhou First People's Hospital30
招募中
2 期
Fecal microbiota transplantation for intractable gastrointestinal diseases(FEMIGI study)1)Clostridium difficile infection 2)Crohn disease, ulcerative colitis 3)Chronic Enteropathy associatJPRN-jRCTs041190021Ohmiya Naoki50
招募中
2 期
A-FMT for active UCMild to moderate ulcerative colitisUlcerative colitisJPRN-jRCTs031220542agahara Akihito37