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

Stroke, Ischemic Clinical Trial

— PRISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954846
• Other study ID #: PRISE
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Ludwig-Maximilians - University of Munich
• Contact: Arthur Liesz, Prof. Dr.
• Phone: 089 4400 46110
• Email: Arthur.Liesz[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 157
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Dietary Supplement:
• OMNi-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
• Placebo
The Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9.

Locations

Country	Name	City	State
Germany	Ludwig Maximilian University Munich, University Hospital, Site Großhadern	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alpha diversity, determined via Shannon index		3 Months after stroke onset/Begin of diet supplementation
Primary	Alpha diversity, determined via phylogenetic diversity index		3 Months after stroke onset/Begin of diet supplementation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Beta diversity, determined via Bray-Curtis dissimilarity		3 Months after stroke onset/Begin of diet supplementation
Secondary	Beta diversity, determined via UniFrac		3 Months after stroke onset/Begin of diet supplementation