A Randomized Double Blinded Placebo Controlled Study on the Effects of Dietary Supplementation With a Probiotic on Stroke Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Auswirkungen Eines Probiotischen Nahrungsergänzungsmittels Auf Das Darmmikrobiom Von Schlaganfallpatienten (PRISE)

Conditions
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Stroke, Ischemic, Dysbiosis

Intervention / Treatment
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* Dietary Supplement: OMNi-BiOTiC SR-9
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMNi-BiOTiC SR-9<br>Treatment is taken twice a day for 3 months | Dietary Supplement: OMNi-BiOTiC SR-9<br>* 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<br>|
| Placebo Comparator: Control<br>Placebo is taken twice a day for 3 months | Dietary Supplement: Placebo<br>* The Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MOCA) | Range of achievable values is 0 - 31, low values are associated with impaired cognitive function | 3 Months after stroke onset/Begin of diet supplementation | 
| Becks Depression Inventory (BDI) | Range of achievable values is 0 - 63, high values are associated with mild (12-19), moderate (20-26) and severe (30-63) depression | 3 Months after stroke onset/Begin of diet supplementation | 
| National Institute of Health Stroke Scale (NIHSS) | Range of achievable values is 0 - 42, high values are associated with more advanced impairment due to stroke | 3 Months after stroke onset/Begin of diet supplementation | 
| Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS) | Range of achievable values is 13 - 91, high values are associated with more pronounced gastrointestinal symptoms (i.e. pain, diarrhea, discomfort) | 3 Months after stroke onset/Begin of diet supplementation | 
| Modified Rankin Scale (mRS) | Range of achievable values is 0 - 5, high values are associated with loss of mobility and autonomy | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut-Brain Axis, Probiotics, Food supplements, Microbiome