NCT04688138

Gut Microbiota and Serum Markers for Cognitive Impairment and Poor Prognosis After Ischemic Stroke

Status unknown Last updated 2 August 2021

What this trial tests

trial in Ischemic Stroke in 600 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Nanfang Hospital, Southern Medical University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	600
Start date	1 June 2020
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across China

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 75, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Post-stroke cognitive impairment(PSCI) is one of the most important factors causing disabilities after stroke. Recent study found that gut microbiota plays a key role in neurological diseases. Two recent small sample studies reported gut dysbiosis in PSCI patients. In order to further verify the relationship between PSCI and gut microbiota and the predictive value of gut microbiota and serum markers for cognitive impairment and poor prognosis after ischemic stroke. The study intended to collect stool specimens of patients with acute ischemic stroke and assess their cognitive psychological state, and to establish a prospective multi-center follow-up cohort to explore the correlation between the dynamic changes of intestinal flora in patients with stroke and PSCI and poor prognosis of stroke.

Publications & conference data

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

1. Gut microbiota is causally associated with poststroke cognitive impairment through lipopolysaccharide and butyrate.
   Wang H, Zhang M, Li J, Liang J, et al · · 2022 · cited 97× · PMID 35379265 · DOI 10.1186/s12974-022-02435-9
2. Gut microbiota-mediated ursodeoxycholic acids regulate the inflammation of microglia through TGR5 signaling after MCAO.
   Zhang F, Deng Y, Wang H, Fu J, et al · · 2024 · cited 32× · PMID 37989444 · DOI 10.1016/j.bbi.2023.11.021
3. Low Serum Superoxide Dismutase Is Associated With a High Risk of Cognitive Impairment After Mild Acute Ischemic Stroke.
   Zhang MS, Liang JH, Yang MJ, Ren YR, et al · · 2022 · cited 24× · PMID 35296032 · DOI 10.3389/fnagi.2022.834114
4. Association between oral microbial dysbiosis and poor functional outcomes in stroke-associated pneumonia patients.
   Ren Y, Liang J, Li X, Deng Y, et al · · 2023 · cited 12× · PMID 37875813 · DOI 10.1186/s12866-023-03057-8
5. The Spouses of Stroke Patients Have a Similar Oral Microbiome to Their Partners with an Elevated Risk of Stroke.
   Wang H, Yang M, Cheng S, Ren Y, et al · · 2022 · cited 6× · PMID 36422358 · DOI 10.3390/microorganisms10112288
6. Activated sympathetic nerve post stroke downregulates Toll-like receptor 5 and disrupts the gut mucosal barrier.
   Wang H, Li J, Wu G, Lin X, et al · · 2024 · cited 4× · PMID 39383869 · DOI 10.1016/j.xcrm.2024.101754
7. Host-Microbial Cometabolite Ursodeoxycholic Acid Protects Against Poststroke Cognitive Impairment.
   Gao X, Zhang F, Zhang J, Ma Y, et al · · 2025 · cited 2× · PMID 40265603 · DOI 10.1161/jaha.124.038862
8. Association between oral microbial nitrate metabolism and poor prognosis in acute ischemic stroke patients with a history of hypertension.
   Ren Y, Liang J, Hu W, Xie J, et al · · 2024 · cited 2× · PMID 39055280 · DOI 10.1080/20002297.2024.2382620