NCT04954846 (PRISE) is a NA clinical trial of OMNi-BiOTiC SR-9 in Stroke, Ischemic, sponsored by Ludwig-Maximilians - University of Munich.

Who is sponsoring NCT04954846?

NCT04954846 is sponsored by Ludwig-Maximilians - University of Munich.

What drugs are being tested in NCT04954846?

Interventions in NCT04954846: OMNi-BiOTiC SR-9, Placebo.

What condition does NCT04954846 study?

NCT04954846 studies Stroke, Ischemic, Dysbiosis.

Is NCT04954846 still recruiting?

NCT04954846 is currently status unknown. Last updated 17 August 2022.

Last reviewed 2022-08-17 · How we verify

NCT04954846: PRISE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown NA Last updated 17 August 2022

What this trial tests

NA trial testing OMNi-BiOTiC SR-9 in Stroke, Ischemic in 157 participants. Status unknown.

Timeline

18 January 2021

Primary endpoint
30 September 2023

30 December 2023

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	157
Start date	18 January 2021
Primary completion	30 September 2023
Estimated completion	30 December 2023
Sites	1 location across Germany

Drugs / interventions tested

OMNi-BiOTiC SR-9
Placebo

Conditions studied

Stroke, Ischemic — all drugs for Stroke, Ischemic →
Dysbiosis — all drugs for Dysbiosis →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, any sex, with Stroke, Ischemic or Dysbiosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The gut-brain axis in ischemic stroke: its relevance in pathology and as a therapeutic target.
Benakis C, Liesz A. · · 2022 · cited 27× · PMID 36401322 · DOI 10.1186/s42466-022-00222-8
The interaction between intestinal microenvironment and stroke.
Zhao L, Xiao J, Li S, Guo Y, et al · · 2023 · cited 24× · PMID 37309254 · DOI 10.1111/cns.14275
The immunology of stroke and dementia.
Iadecola C, Anrather J. · · 2025 · cited 15× · PMID 39813992 · DOI 10.1016/j.immuni.2024.12.008

Verify or expand the search:

Other recruiting trials for Stroke, Ischemic

Currently open trials in the same condition.

NCT07456956 — HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke · NA · recruiting
NCT06658197 — Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke · Phase 3 · recruiting
NCT07282041 — Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis · Phase 2, PHASE3 · recruiting
NCT07135089 — Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban · Phase 3 · recruiting
NCT07047014 — Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ische · Phase 3 · recruiting

Other Ludwig-Maximilians - University of Munich trials

Trials by the same sponsor.

NCT07514520 — Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION · active not recruiting
NCT07504965 — Dementia-friendly Apothecaries as a Resource for Mental Heath in the Elderly · recruiting
NCT07100548 — A Qualitative Analysis of Youth Responses to Depression Education Delivered on Social Media · completed
NCT07061600 — Enhancing Depression Literacy and Reducing Stigma in Adolescents Through Social Media · NA · completed
NCT06749106 — Plaque Imaging in Routine Care to Detect Intraplaque Hemorrhage · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04954846 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich
Last refreshed: 17 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04954846.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing