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临床试验/CTRI/2025/09/094902
CTRI/2025/09/094902尚未招募不适用

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

NIMHANS1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NIMHANS
入组人数
90
试验地点
1
主要终点
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).

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

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).

时间窗: 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.

次要结局

  • 1) Correlation between specific gut microbiome signatures and the occurrence/severity of cerebral vasospasm (CV) and delayed cerebral ischemia (DCI) in aSAH patients.

研究者

发起方
NIMHANS
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr HB Veenakumari

NIMHANS

研究点 (1)

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