Auswirkungen Eines Probiotischen Nahrungsergänzungsmittels Auf Das Darmmikrobiom Von Schlaganfallpatienten (PRISE)
试验速览
- 阶段
- 不适用
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Alpha diversity, determined via Shannon index
研究概览
简要总结
The aim of this study is to determine the effects of an intervention using a commercially available probiotic in a cohort of acute stroke patients. In order to determine this, a double blinded, randomised and placebo-controlled study design was chosen.
详细描述
Patients are recruited from the Stroke Unit of the Ludwig Maximilians University Munich within seven days of stroke onset. Recruited patients are then randomly assigned to either the Control or Treatment group and subsequently take the commercially available probiotic, or the placebo, twice a day for 3 months. At this point, study participants present themselves for routine clinical examination at the outpatient clinic of the Institute for Stroke and Dementia Research (ISD). During these examinations, blood and stool samples are collected for metabolomic and metagenomic analysis. Additionally, questionnaires concerning cognitive function (MOCA), depression (BDI) and general gastrointestinal status (GSRS-IBS) are completed.
Clinical data from both acute admission and three month follow-up are also collected for the purposes of this study.
Furthermore, members of the same household as the study participants are asked to donate a stool sample. These samples will be used to create a reference cohort for a paired matching approach with the Treatment and Control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of ischemic stroke with onset in past 7 days
- •Treatment received in the Stroke Unit of the LMU University Hospital, location Großhadern
排除标准
- •Chronic immunological disease
- •Severe gastrointestinal disease
- •Colectomy
- •Artificial intestinal outlet (ostomy)
- •Liver cirrhosis, pancreatitis, gastritis, cholecystitis (or other acute gastrointestinal diseases)
- •Chronic alcohol abuse
- •Terminal prognosis
研究组 & 干预措施
OMNi-BiOTiC SR-9
Treatment is taken twice a day for 3 months
干预措施: OMNi-BiOTiC SR-9 (Dietary Supplement)
Control
Placebo is taken twice a day for 3 months
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Alpha diversity, determined via Shannon index
时间窗: 3 Months after stroke onset/Begin of diet supplementation
Alpha diversity, determined via phylogenetic diversity index
时间窗: 3 Months after stroke onset/Begin of diet supplementation
次要结局
- Becks Depression Inventory (BDI)(3 Months after stroke onset/Begin of diet supplementation)
- National Institute of Health Stroke Scale (NIHSS)(3 Months after stroke onset/Begin of diet supplementation)
- Montreal Cognitive Assessment (MOCA)(3 Months after stroke onset/Begin of diet supplementation)
- Modified Rankin Scale (mRS)(3 Months after stroke onset/Begin of diet supplementation)
- Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS)(3 Months after stroke onset/Begin of diet supplementation)
- Beta diversity, determined via Bray-Curtis dissimilarity(3 Months after stroke onset/Begin of diet supplementation)
- Beta diversity, determined via UniFrac(3 Months after stroke onset/Begin of diet supplementation)
研究者
Prof. Dr. med. Arthur Liesz
Professor Dr. med. Arthur Liesz
Ludwig-Maximilians - University of Munich