NCT04954846

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2.7 years

First QC Date

June 18, 2021

Last Update Submit

August 16, 2022

Conditions

Stroke, IschemicDysbiosis

Keywords

Gut-Brain AxisProbioticsFood supplementsMicrobiome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Montreal Cognitive Assessment (MOCA)

    3 Months after stroke onset/Begin of diet supplementation

  • Becks Depression Inventory (BDI)

    3 Months after stroke onset/Begin of diet supplementation

  • National Institute of Health Stroke Scale (NIHSS)

    3 Months after stroke onset/Begin of diet supplementation

  • Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS)

    3 Months after stroke onset/Begin of diet supplementation

  • Modified Rankin Scale (mRS)

    3 Months after stroke onset/Begin of diet supplementation

  • +2 more secondary outcomes

Study Arms (2)

OMNi-BiOTiC SR-9

EXPERIMENTAL

Treatment is taken twice a day for 3 months

Dietary Supplement: OMNi-BiOTiC SR-9

Control

PLACEBO COMPARATOR

Placebo is taken twice a day for 3 months

Dietary Supplement: Placebo

Interventions

OMNi-BiOTiC SR-9DIETARY_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

OMNi-BiOTiC SR-9
PlaceboDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ischemic stroke with onset in past 7 days
  • Treatment received in the Stroke Unit of the LMU University Hospital, location Großhadern

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Maximilian University Munich, University Hospital, Site Großhadern

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeDysbiosis

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Arthur Liesz, Prof. Dr.

CONTACT

089 4400 46110Arthur.Liesz@med.uni-muenchen.de

Philip Melton

CONTACT

089 4400 46333philip.melton@med.uni-muenchen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med. Arthur Liesz

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 8, 2021

Study Start

January 18, 2021

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations

DE(1)