Stroke, IschemicPRISENCT04954846
A Randomized Double Blinded Placebo Controlled Study on the Effects of Dietary Supplementation With a Probiotic on Stroke Patients
A study testing OMNi-BiOTiC SR-9 in people with Stroke, Ischemic and Dysbiosis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Dysbiosis
- What is being tested?
- OMNi-BiOTiC SR-9
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic stroke with onset in past 7 days
- Treatment received in the Stroke Unit of the LMU University Hospital, location Großhadern
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Ludwig Maximilian University Munich, University Hospital, Site Großhadern
Munich, Bavaria, 81377
Arthur Liesz, Prof. Dr., 089 4400 46110, arthur.liesz@med.uni-muenchen.de
Philip Melton, 089 4400 46333, philip.melton@med.uni-muenchen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Ischemic, Dysbiosis
- Being tested
- OMNi-BiOTiC SR-9, Placebo
- Keywords
- Gut-Brain Axis, Probiotics, Food supplements, Microbiome
- Medical subject headings
- Ischemic Stroke, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDietary supplement
The Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9.
| Study group | Role | What they receive |
|---|---|---|
| OMNi-BiOTiC SR-9 | Experimental | Treatment is taken twice a day for 3 months Receives: Dietary Supplement: OMNi-BiOTiC SR-9 |
| Control | Placebo comparator | Placebo is taken twice a day for 3 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity, determined via Shannon index
Measured: 3 Months after stroke onset/Begin of diet supplementation
Alpha diversity, determined via phylogenetic diversity index
Measured: 3 Months after stroke onset/Begin of diet supplementation
Secondary outcomes (7)
Montreal Cognitive Assessment (MOCA)
Range of achievable values is 0 - 31, low values are associated with impaired cognitive function
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 3 Months after stroke onset/Begin of diet supplementation
Beta diversity, determined via Bray-Curtis dissimilarity
Measured: 3 Months after stroke onset/Begin of diet supplementation
Beta diversity, determined via UniFrac
Measured: 3 Months after stroke onset/Begin of diet supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start18 Jan 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Arthur Liesz, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954846
- Sponsor's protocol ID
- PRISE
- Acronym
- PRISE
- Status last verified
- Aug 2022
- First submitted
- 18 Jun 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clottes P, Benech N, Dumot C, Jarraud S, Vidal H, Mechtouff L. Gut microbiota and stroke: New avenues to improve prevention and outcome. Eur J Neurol. 2023 Nov;30(11):3595-3604. doi: 10.1111/ene.15770. Epub 2023 Apr 6.
PubMed 36897813
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auswirkungen Eines Probiotischen Nahrungsergänzungsmittels Auf Das Darmmikrobiom Von Schlaganfallpatienten (PRISE)
- ClinicalTrials.gov ID
- NCT04954846
- Acronym / sponsor ID
- PRISE / PRISE
- Conditions
- Stroke, Ischemic, Dysbiosis
- Keywords
- Gut-Brain Axis, Probiotics, Food supplements, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMNi-BiOTiC SR-9 | Experimental | Dietary Supplement: OMNi-BiOTiC SR-9Treatment is taken twice a day for 3 months |
| Control | Placebo comparator | Dietary Supplement: PlaceboPlacebo is taken twice a day for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ischemic stroke with onset in past 7 days
- Treatment received in the Stroke Unit of the LMU University Hospital, location Großhadern
Key exclusion criteria (7 listed)
- Chronic immunological disease
- Severe gastrointestinal disease
- Colectomy
- Artificial intestinal outlet (ostomy)
- Liver cirrhosis, pancreatitis, gastritis, cholecystitis (or other acute gastrointestinal diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNi-BiOTiC SR-9The 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 | Dietary supplement | OMNi-BiOTiC SR-9 |
| PlaceboThe Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9. | Dietary supplement | Control |
Primary outcome
Alpha diversity, determined via Shannon index
Time frame: 3 Months after stroke onset/Begin of diet supplementation
Alpha diversity, determined via phylogenetic diversity index
Time frame: 3 Months after stroke onset/Begin of diet supplementation
7 secondary outcomes
Montreal Cognitive Assessment (MOCA)
Time frame: 3 Months after stroke onset/Begin of diet supplementation
Becks Depression Inventory (BDI)
Time frame: 3 Months after stroke onset/Begin of diet supplementation
National Institute of Health Stroke Scale (NIHSS)
Time frame: 3 Months after stroke onset/Begin of diet supplementation
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrom (GSRS-IBS)
Time frame: 3 Months after stroke onset/Begin of diet supplementation
Modified Rankin Scale (mRS)
Time frame: 3 Months after stroke onset/Begin of diet supplementation
Beta diversity, determined via Bray-Curtis dissimilarity
Time frame: 3 Months after stroke onset/Begin of diet supplementation
Beta diversity, determined via UniFrac
Time frame: 3 Months after stroke onset/Begin of diet supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 36897813Clottes P, Benech N, Dumot C, Jarraud S, Vidal H, Mechtouff L. Gut microbiota and stroke: New avenues to improve prevention and outcome. Eur J Neurol. 2023 Nov;30(11):3595-3604. doi: 10.1111/ene.15770. Epub 2023 Apr 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNi-BiOTiC SR-9 in people with Stroke, Ischemic and Dysbiosis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur Liesz, Prof. Dr. (089 4400 46110, Arthur.Liesz@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha diversity, determined via Shannon index (time frame: 3 Months after stroke onset/Begin of diet supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.