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The Gut-Brain Connection: A Study to Find Early Predictors for Patients with a Brain Bleed.

Integrated Omics approach to Explore Gut Microbiome Signature, Gut integrity biomarkers and Short-chain fatty acid profile, predictive tool in Aneurysmal Subarachnoid Hemorrhage - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094902
Enrollment
90
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G968- Other specified disorders of central nervous system

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: NIL: NIL

Sponsors

NIMHANS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH), confirmed by imaging 2)Admission to the ICU/ ward within 72 hours of symptom onset. 3)Consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Pre-existing neurological or gastrointestinal disorders 2) Recent use of antibiotics or probiotics within 4 weeks prior to admission. 3) Non-aneurysmal subarachnoid hemorrhage 4) Mycotic aneurysms or aneurysms within arteriovenous malformations. 5) Pregnancy

Design outcomes

Primary

MeasureTime frame
Identification and comparison of gut microbiome composition, short-chain fatty acid (SCFA) levels, and gut integrity biomarkers (zonulin, occludin, claudin-5) between aneurysmal subarachnoid hemorrhage (aSAH) patients and healthy controls, and their association with the development of cerebral vasospasm (CV) and delayed cerebral ischemia (DCI).Timepoint: All biological samples (blood and stool) will be collected within 72 hours of diagnosis in aSAH patients, and once at enrollment in healthy controls. Clinical outcomes (CV and DCI) will be monitored daily for 14 days or until discharge.

Secondary

MeasureTime frame
1) Correlation between specific gut microbiome signatures and the occurrence/severity of cerebral vasospasm (CV) and delayed cerebral ischemia (DCI) in aSAH patients. 2)Association of altered short-chain fatty acid (SCFA) levels (acetate, propionate, and butyrate) with clinical outcomes in aSAH, including CV and DCI. 3)Correlation between blood levels of gut barrier integrity biomarkers (zonulin, occludin, claudin-5) and radiological or clinical evidence of cerebral vasospasm and delayed cerebral ischemia. 4)Comparison of gut microbiome diversity (alpha and beta diversity) between aSAH patients and healthy controls. 5)Exploratory identification of potential microbial or biomarker-based predictive tools for clinical outcomes in aSAH.Timepoint: All biological samples (blood and stool) will be collected within 72 hours of diagnosis in aSAH patients, and once at enrollment in healthy controls. Clinical outcomes (CV and DCI) will be monitored daily for 14 days or until discharge.

Countries

India

Contacts

Public ContactDr Dhaval Shukla

NIMHANS

rosemaryshajiv@gmail.com7025087746

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026