Auswirkungen Eines Probiotischen Nahrungsergänzungsmittels Auf Das Darmmikrobiom Von Schlaganfallpatienten (PRISE)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 157
- Locations
- 2
- Primary Endpoint
- Alpha diversity, determined via Shannon index
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of ischemic stroke with onset in past 7 days
- •Treatment received in the Stroke Unit of the LMU University Hospital, location Großhadern
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Alpha diversity, determined via Shannon index
Time Frame: 3 Months after stroke onset/Begin of diet supplementation
Alpha diversity, determined via phylogenetic diversity index
Time Frame: 3 Months after stroke onset/Begin of diet supplementation
Secondary Outcomes
- 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 UniFrac(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)
Investigators
Prof. Dr. med. Arthur Liesz
Professor Dr. med. Arthur Liesz
Ludwig-Maximilians - University of Munich