Clinical trial NCT04954846: A Randomized Double Blinded Placebo Controlled Study on the Effects of Dietary Supplementation With a Probiotic on Stroke Patients
Official title: Auswirkungen Eines Probiotischen Nahrungsergänzungsmittels Auf Das Darmmikrobiom Von Schlaganfallpatienten (PRISE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Dysbiosis
Keywords: Gut-Brain Axis
Probiotics
Food supplements
Microbiome
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alpha diversity, determined via Shannon index
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
measure: Alpha diversity, determined via phylogenetic diversity index
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
measure: Becks Depression Inventory (BDI)
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
measure: Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS)
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
measure: Modified Rankin Scale (mRS)
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
measure: Beta diversity, determined via Bray-Curtis dissimilarity
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
measure: Beta diversity, determined via UniFrac
timeFrame: 3 Months after stroke onset/Begin of diet supplementation
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilian University Munich, University Hospital, Site Großhadern
state: Bavaria
Study officials:
References: