Gut Leakage' in Dengue (GLiD)
Gut Leakage and Sonographic Abdominal Changes in Hospitalized Dengue Patients: an Observational Study
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. We 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. We 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, we 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Chattogram Division
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Chittagong, Chattogram Division, Bangladéš, 4203
- Department of Medicine, Chittagong Medical College
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Kontakt:
- Rabiul Alam Md Erfan Uddin, FCPS
- Telefonní číslo: +8801711129798
- E-mail: rubelerfan@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Adult (≥18 years) male and non-pregnant female patients with confirmed dengue (positive NS1 antigen and/or IgM) admitted to the Department of Medicine, Chittagong Medical College Hospital will be recruited. Blood biomarkers will be collected at enrollment for all patients. Those initially classified as non-severe dengue will have no repeat sampling unless they progress to severe disease, in which case a second sample will be obtained within 24 hours. Serum ALT and blood culture will be performed on day 7 of illness. Stool samples will be collected on day 7 from 100 patients for gut microbiota analysis.
Additionally, 10 healthy adult participants (5 male, 5 female) will be recruited from patient attendants. They will undergo a single visit for baseline biomarker sampling and POCUS, serving as healthy controls for comparison.
Popis
Inclusion Criteria:
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)
Exclusion Criteria:
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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.
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Level of gut leakage marker in blood and gastrointestinal findings in POCUS
Časové okno: On enrollment, day of development of severity if non severe at enrolment, up to 28 days
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On enrollment, day of development of severity if non severe at enrolment, up to 28 days
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Document clinical events occurred in dengue patients
Časové okno: Through study completion, an average of 28 days
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Demographic: Age, gender, BMI Clinical: respiratory rate, blood pressure, heart rate, ascites, pleural effusion, any major bleeding, GCS |
Through study completion, an average of 28 days
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Document clinical events occurred in dengue patients
Časové okno: Day of enrolment/ 4th or day 7 of illness
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For mSOFA: SpO2, FiO2 |
Day of enrolment/ 4th or day 7 of illness
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Další výstupní opatření
Měření výsledku |
Časové okno |
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Level of I-FABP Level of LPS, Level of LBP, Level of sCD14, Positive Blood culture
Časové okno: On enrollment in all cases, if clinical severity occur in initial non-severe group, 24 hours within developing severity
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On enrollment in all cases, if clinical severity occur in initial non-severe group, 24 hours within developing severity
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Detectable fluid collection in abdomen, loss of haustration, loss of normal multi-layered appearance
Časové okno: Enrollment day, day of development of clinical severity
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Enrollment day, day of development of clinical severity
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Measurement of gall bladder wall thickness, intestinal wall thickness
Časové okno: Enrollment day, day of development of clinical severity
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Enrollment day, day of development of clinical severity
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Alteration of gut microbiota
Časové okno: Day seven of illness
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Day seven of illness
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Organ failure
Časové okno: Through study completion, an average of 28 day
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Through study completion, an average of 28 day
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Development of shock
Časové okno: Through study completion, an average of 28 day
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Through study completion, an average of 28 day
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci přenášené vektorem
- Nemoci přenášené komáry
- Patologické procesy
- Infekce
- RNA virové infekce
- Virová onemocnění
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Arbovirové infekce
- Flavivirové infekce
- Infekce Flaviviridae
- Hemoragické horečky, virové
- Patologické stavy, příznaky a symptomy
- Dengue
- Střevní nemoci
- Ascites
- Závažná horečka dengue
Další identifikační čísla studie
- VIR26001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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