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

Not Applicable

• Conditions: Stroke, Ischemic; Dysbiosis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: OMNi-BiOTiC SR-9

• Registration Number: NCT04954846
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 157

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo is taken twice a day for 3 months
OMNi-BiOTiC SR-9	OMNi-BiOTiC SR-9	Treatment is taken twice a day for 3 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Becks Depression Inventory (BDI)	3 Months after stroke onset/Begin of diet supplementation	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)	3 Months after stroke onset/Begin of diet supplementation	Range of achievable values is 0 - 42, high values are associated with more advanced impairment due to stroke
Montreal Cognitive Assessment (MOCA)	3 Months after stroke onset/Begin of diet supplementation	Range of achievable values is 0 - 31, low values are associated with impaired cognitive function
Modified Rankin Scale (mRS)	3 Months after stroke onset/Begin of diet supplementation	Range of achievable values is 0 - 5, high values are associated with loss of mobility and autonomy
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS)	3 Months after stroke onset/Begin of diet supplementation	Range of achievable values is 13 - 91, high values are associated with more pronounced gastrointestinal symptoms (i.e. pain, diarrhea, discomfort)
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

Trial Locations

Locations (1)

Ludwig Maximilian University Munich, University Hospital, Site Großhadern; 🇩🇪 Munich, Bavaria, Germany