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

Primary Purpose

Stroke, Ischemic, Dysbiosis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
OMNi-BiOTiC SR-9
Placebo
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Gut-Brain Axis, Probiotics, Food supplements, Microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ludwig Maximilian University Munich, University Hospital, Site GroßhadernRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OMNi-BiOTiC SR-9

Control

Arm Description

Treatment is taken twice a day for 3 months

Placebo is taken twice a day for 3 months

Outcomes

Primary Outcome Measures

Alpha diversity, determined via Shannon index
Alpha diversity, determined via phylogenetic diversity index

Secondary Outcome Measures

Montreal Cognitive Assessment (MOCA)
Range of achievable values is 0 - 31, low values are associated with impaired cognitive function
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
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
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)
Modified Rankin Scale (mRS)
Range of achievable values is 0 - 5, high values are associated with loss of mobility and autonomy
Beta diversity, determined via Bray-Curtis dissimilarity
Beta diversity, determined via UniFrac

Full Information

First Posted
June 18, 2021
Last Updated
August 16, 2022
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT04954846
Brief Title
A Randomized Double Blinded Placebo Controlled Study on the Effects of Dietary Supplementation With a Probiotic on Stroke Patients
Acronym
PRISE
Official Title
Auswirkungen Eines Probiotischen Nahrungsergänzungsmittels Auf Das Darmmikrobiom Von Schlaganfallpatienten (PRISE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Dysbiosis
Keywords
Gut-Brain Axis, Probiotics, Food supplements, Microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
157 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMNi-BiOTiC SR-9
Arm Type
Experimental
Arm Description
Treatment is taken twice a day for 3 months
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo is taken twice a day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
OMNi-BiOTiC SR-9
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9.
Primary Outcome Measure Information:
Title
Alpha diversity, determined via Shannon index
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Title
Alpha diversity, determined via phylogenetic diversity index
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MOCA)
Description
Range of achievable values is 0 - 31, low values are associated with impaired cognitive function
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Title
Becks Depression Inventory (BDI)
Description
Range of achievable values is 0 - 63, high values are associated with mild (12-19), moderate (20-26) and severe (30-63) depression
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Title
National Institute of Health Stroke Scale (NIHSS)
Description
Range of achievable values is 0 - 42, high values are associated with more advanced impairment due to stroke
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Title
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS)
Description
Range of achievable values is 13 - 91, high values are associated with more pronounced gastrointestinal symptoms (i.e. pain, diarrhea, discomfort)
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Title
Modified Rankin Scale (mRS)
Description
Range of achievable values is 0 - 5, high values are associated with loss of mobility and autonomy
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Title
Beta diversity, determined via Bray-Curtis dissimilarity
Time Frame
3 Months after stroke onset/Begin of diet supplementation
Title
Beta diversity, determined via UniFrac
Time Frame
3 Months after stroke onset/Begin of diet supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Liesz, Prof. Dr.
Phone
089 4400 46110
Email
Arthur.Liesz@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Melton
Phone
089 4400 46333
Ext
+49
Email
philip.melton@med.uni-muenchen.de
Facility Information:
Facility Name
Ludwig Maximilian University Munich, University Hospital, Site Großhadern
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Liesz, Prof. Dr.
Phone
089 4400 46110
Email
arthur.liesz@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Philip Melton
Phone
089 4400 46333
Email
philip.melton@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Arthur Liesz, Prof. Dr.

12. IPD Sharing Statement

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

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