Dysbiosis, Stroke, Ischemic
Conditions
Keywords
Gut-Brain Axis, Probiotics, Food supplements, Microbiome
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.
Interventions
DIETARY_SUPPLEMENTOMNi-BiOTiC SR-9
The Probiotic contains the following ingredients: Maize Starch, Maltodextrin, Inulin, Potassium Chloride, Hydrolysed rice protein, Magnesium Sulphate, Fructooligosaccharides, Amylase, Manganese Sulphate Additionally, the following bacterial strains are included: Lactobacillus Casei W56, Lactobacillus Acidophilus W22, Lactobacillus Paracasei W20, Bifidobacterium lactis W51, Lactobacillus salivarius W24, Lactococcus lactis W19, Bifidobacterium lactis W52, Lactobacillus plantarum, Bifidobacterium bifidum W23
DIETARY_SUPPLEMENTPlacebo
The Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9.
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alpha diversity, determined via Shannon index | 3 Months after stroke onset/Begin of diet supplementation |
| Alpha diversity, determined via phylogenetic diversity index | 3 Months after stroke onset/Begin of diet supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) | 3 Months after stroke onset/Begin of diet supplementation | Range of achievable values is 0 - 42, high values are associated with more advanced impairment due to stroke |
| Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS) | 3 Months after stroke onset/Begin of diet supplementation | Range of achievable values is 13 - 91, high values are associated with more pronounced gastrointestinal symptoms (i.e. pain, diarrhea, discomfort) |
| Montreal Cognitive Assessment (MOCA) | 3 Months after stroke onset/Begin of diet supplementation | Range of achievable values is 0 - 31, low values are associated with impaired cognitive function |
| 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 | — |
| Modified Rankin Scale (mRS) | 3 Months after stroke onset/Begin of diet supplementation | Range of achievable values is 0 - 5, high values are associated with loss of mobility and autonomy |
| Becks Depression Inventory (BDI) | 3 Months after stroke onset/Begin of diet supplementation | Range of achievable values is 0 - 63, high values are associated with mild (12-19), moderate (20-26) and severe (30-63) depression |
Countries
Germany
Contacts
Primary ContactArthur Liesz, Prof. Dr.
Backup ContactPhilip Melton
Outcome results
None listed