Gut Leakage and Sonographic Abdominal Changes in Hospitalized Dengue Patients: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 2
研究概览
简要总结
Dengue infections are imposing an increasing global burden of disease, particularly in tropical countries such as Bangladesh. The World Health Organization (WHO) has identified Dengue virus as a priority pathogen for the development of medical counter measures because of the high risk of it causing a Public Health Emergency of Intenational Concern (PHEIC). Warning signs for severe dengue, associated with mortality, include gastrointestinal features including abdominal pain, vomiting, and diarrhoea. Multiple alterations may occur in in the gastrointestinal tract that could lead to damaging of the gastrointestinal wall and gut leakage, the translocation of gut metabolites into the bloodstream. Study team hypothesize that gut leakage initiates inflammatory processes underlying the further development of severe dengue, including features associated with plasma leakage.
This study aims to investigate intestinal barrier dysfunction (gut leakage) in dengue infection by detecting the translocation of gut-derived bacteria and their products (Lipopolysaccharides, LPS binding protein, sCD14, I-Fatty Acid Binding Protein) into the bloodstream. Study team will recruit hospitalized adult dengue patients (18 years and older) presenting with warning signs or severe disease in a tertiary care public hospital at Chattogram, Bangladesh. Circulating biomarkers indicative of gut permeability and microbial translocation will be measured to assess their presence and association with disease severity.
Abdominal ultrasonography will be performed to characterize gastrointestinal alterations and determine their correlation with biochemical markers of gut leakage and clinical severity. In addition, study team will analyze the gut bacteriome from stool/ rectal swab of these patients to explore whether dengue infection induces compositional changes in intestinal microbiota and whether such alterations are linked to gut leakage or disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dengue participants
- •Participant/ legally authorised representative willing and able to give informed consent for participation in the study.
- •Male or Female, adults ≥18 years
- •Diagnosed as a case of Dengue on the basis of clinical features and positive NS1 antigen and/or IgM dengue antibody
- •Hospitalized in medicine or dengue ward in Chittagong Medical College Hospital.
- •Enrolled within 24 hours of hospitalization.
- •Healthy participants
- •Participant/ legally authorised representative willing and able to give informed consent for participation in the study.
- •Male or Female, adults ≥18 years
- •Clinically healthy with no acute or chronic illness
- •Attendant of a dengue patient (not a patient)
排除标准
- •Dengue participants
- •Unable to provide consent or participate in follow-up procedures
- •Known chronic gastrointestinal (GI) disease affecting intestinal permeability (IBD, celiac disease), chronic liver disease, active chronic diarrhoea, short bowel loop syndrome, recent (<3 months) major GI surgery.
- •Immunosuppression (for example chemotherapy, high-dose steroids), advanced chronic kidney disease, decompensated heart failure.
- •Drugs that can alter the level of biomarkers in blood like metformin, statin, probiotics, steroid within last 48 hours of hospitalization.
- •Pregnancy
- •Healthy participants
- •Unable to provide consent
- •Known chronic gastrointestinal (GI) disease affecting intestinal permeability (IBD, celiac disease), chronic liver disease, active chronic diarrhoea, short bowel loop syndrome, recent (<3 months) major GI surgery.
- •Immunosuppression (for example chemotherapy, high-dose steroids), advanced chronic kidney disease, decompensated heart failure.
- •Drugs that can alter the level of biomarkers in blood like metformin, statin, probiotics, steroid within last 48 hours of hospitalization.
- •Pregnancy
- •History of current or recent dengue or other arbo viral infection
研究组 & 干预措施
Severe dengue
All enrolled dengue patients will have blood biomarkers at enrolment whether they present with non-severe or severe dengue. If participant enrolled as non-severe and do not progress to severe dengue, they will be no second test for biomarkers but if they developed clinical feature of severity, a second biomarker sample will be collected within 24 hours of developing clinical severity. S ALT and Blood culture will be performed on day 7 of illness for all dengue patients. Stool will be collected on day 7 of illness from 100 patients for testing gut microbiota.
Non-severe dengue
All enrolled dengue patients will have blood biomarkers at enrolment whether they present with non-severe or severe dengue. If participant enrolled as non-severe and do not progress to severe dengue, they will be no second test for biomarkers but if they developed clinical feature of severity, a second biomarker sample will be collected within 24 hours of developing clinical severity. S ALT and Blood culture will be performed on day 7 of illness for all dengue patients. Stool will be collected on day 7 of illness from 100 patients for testing gut microbiota.
Healthy individual
These participants will undergo only one study visit for baseline biomarker sampling, baseline POCUS and will not undergo follow-up. Their results will serve as healthy control reference values for comparison with biomarker findings in dengue patients.