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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysbiosis; Stroke, Ischemic
• Intervention / Treatment: Dietary supplement: OMNi-BiOTiC SR-9; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 157
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arthur Liesz, Prof. Dr.; Phone Number: 089 4400 46110; Email: arthur.liesz@med.uni-muenchen.de
• Study Contact Backup: Name: Philip Melton; Phone Number: +49 089 4400 46333; Email: philip.melton@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Ludwig Maximilian University Munich, University Hospital, Site Großhadern
      • Contact: Arthur Liesz, Prof. Dr.; Phone Number: 089 4400 46110; Email: arthur.liesz@med.uni-muenchen.de
      • Contact: Philip Melton; Phone Number: 089 4400 46333; Email: philip.melton@med.uni-muenchen.de
      • Principal Investigator: Arthur Liesz, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OMNi-BiOTiC SR-9; Treatment is taken twice a day for 3 months	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_COMPARATOR: Control; Placebo is taken twice a day for 3 months	Dietary supplement: Placebo; The Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9.

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2021
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (ACTUAL): July 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Microbiome; Probiotics; Gut-Brain Axis; Food supplements
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Dysbiosis
• Other Study ID Numbers: PRISE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No