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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2023-12-30

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.

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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.

Conditions

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Stroke, Ischemic Dysbiosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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OMNi-BiOTiC SR-9

Treatment is taken twice a day for 3 months

Group Type EXPERIMENTAL

OMNi-BiOTiC SR-9

Intervention Type DIETARY_SUPPLEMENT

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

Control

Placebo is taken twice a day for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes