| CTRI Number |
CTRI/2025/09/094902 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
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Public Title of Study
|
The Gut-Brain Connection: A Study to Find Early Predictors for Patients with a Brain Bleed.
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Scientific Title of Study
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Integrated Omics approach to Explore Gut Microbiome Signature, Gut integrity biomarkers
and Short-chain fatty acid profile, predictive tool in Aneurysmal Subarachnoid Hemorrhage |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HB Veenakumari |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuromicrobiology
National Institute of Mental Health and Neurosciences (NIMHANS)
Bengaluru
Bangalore KARNATAKA 560029 India |
| Phone |
9449084851 |
| Fax |
|
| Email |
docveenas2002@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rosemary Shaji V |
| Designation |
Ph D Scholar |
| Affiliation |
NIMHANS |
| Address |
Department of Neuromicrobiology
National Institute of Mental Health and Neurosciences (NIMHANS)
Bengaluru
Bangalore KARNATAKA 560029 India |
| Phone |
7025087746 |
| Fax |
|
| Email |
rosemaryshajiv@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Dhaval Shukla |
| Designation |
Professor and HOD |
| Affiliation |
NIMHANS |
| Address |
Department of Neurosurgery
National Institute of Mental Health and Neurosciences (NIMHANS)
Bengaluru
Bangalore KARNATAKA 560029 India |
| Phone |
9898073843 |
| Fax |
|
| Email |
neurodhaval@rediffmail.com |
|
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Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS) |
|
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Primary Sponsor
|
| Name |
NIMHANS |
| Address |
Department of Neuromicrobiology
NIMHANS, Banglore, 560029, Karnatka |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rosemary Shaji V |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Department of Neuromicrobiology
1st floor of Administrative building
Bangalore KARNATAKA |
7025087746
rosemaryshajiv@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Sub-comitte (DESC) |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy, age- and sex-matched individuals without major illnesses or recent use of Antibiotics or probiotics, consenting to participate. |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
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Intervention / Comparator Agent
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| 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). |
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. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
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. |
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. |
|
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Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rosemaryshajiv@gmail.com].
- For how long will this data be available start date provided 03-10-2025 and end date provided 03-10-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
This research proposal outlines a prospective, observational cohort study investigating the role of the gut-brain axis in Aneurysmal Subarachnoid Hemorrhage (aSAH), a life-threatening condition associated with high morbidity and mortality. The study aims to address a critical gap in neurocritical care by exploring how the gut microbiome and its metabolic byproducts influence the disease progression and its further complications, specifically cerebral vasospasm (CV) and delayed cerebral ischemia (DCI). This study adopts an integrated omics approach, combining genomics and metabolomics to provide a holistic view of this complex interaction. A total of 90 participants, 45 aSAH patients and 45 healthy controls will be enrolled, with samples collected within 72 hours of hospital admission. The research methodology includes several key steps such as 16S rRNA gene sequencing will be performed on stool samples to comprehensively profile the gut microbiome signature and identify specific gut bacterial biomarker Simultaneously, plasma levels of short-chain fatty acids (SCFAs), which are vital metabolites known to modulate inflammation and maintain gut barrier integrity, will be quantified using Gas Chromatography-Mass Spectrometry (GC-MS). Furthermore, the study will measure blood levels of key tight-junction proteins, namely Zonulin, Occludin, and Claudin-5, using ELISA to assess the integrity and permeability of the intestinal and blood brain barriers. By establishing a link between gut dysbiosis, altered metabolite profiles, and barrier dysfunction with aSAH outcomes, this research seeks to identify novel biomarkers and create the potential for new diagnostic tools and personalized therapeutic strategies. This groundbreaking study is the first of its kind to be conducted in the Indian population, offering a unique opportunity to understand these mechanisms in a diverse and understudied cohort.
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