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Gut Leakage' in Dengue (GLiD)

3 sierpnia 2026 zaktualizowane przez: University of Oxford

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. 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

190

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Bangladesz
    • Chattogram Division
      • Chittagong, Chattogram Division, Bangladesz, 4203
        • Rekrutacyjny
        • Department of Medicine, Chittagong Medical College
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Level of gut leakage marker in blood and gastrointestinal findings in POCUS
Ramy czasowe: On enrollment, day of development of severity if non severe at enrolment, up to 28 days
On enrollment, day of development of severity if non severe at enrolment, up to 28 days

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Document clinical events occurred in dengue patients
Ramy czasowe: Through study completion, an average of 28 days

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
Document clinical events occurred in dengue patients
Ramy czasowe: Day of enrolment/ 4th or day 7 of illness

For mSOFA:

SpO2, FiO2
Day of enrolment/ 4th or day 7 of illness

Inne miary wyników

Miara wyniku
Ramy czasowe
Level of I-FABP Level of LPS, Level of LBP, Level of sCD14, Positive Blood culture
Ramy czasowe: On enrollment in all cases, if clinical severity occur in initial non-severe group, 24 hours within developing severity
On enrollment in all cases, if clinical severity occur in initial non-severe group, 24 hours within developing severity
Alteration of gut microbiota
Ramy czasowe: Day seven of illness
Day seven of illness
Organ failure
Ramy czasowe: Through study completion, an average of 28 day
Through study completion, an average of 28 day
Development of shock
Ramy czasowe: Through study completion, an average of 28 day
Through study completion, an average of 28 day
Detectable fluid collection in abdomen, loss of haustration, loss of normal multi-layered appearance
Ramy czasowe: Baseline (within 24 hours of enrollment) and at the time of first development of clinical severity, assessed from enrollment until clinical severity occurs, hospital discharge, death, or up to 7 days of hospitalization, whichever occurs first.
Baseline (within 24 hours of enrollment) and at the time of first development of clinical severity, assessed from enrollment until clinical severity occurs, hospital discharge, death, or up to 7 days of hospitalization, whichever occurs first.
Measurement of gall bladder wall thickness, intestinal wall thickness
Ramy czasowe: Baseline (within 24 hours of enrollment) and at the time of first development of clinical severity, assessed from enrollment until clinical severity occurs, hospital discharge, death, or up to 7 days of hospitalization, whichever occurs first.
Baseline (within 24 hours of enrollment) and at the time of first development of clinical severity, assessed from enrollment until clinical severity occurs, hospital discharge, death, or up to 7 days of hospitalization, whichever occurs first.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Oxford

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

31 stycznia 2027

Ukończenie studiów (Szacowany)

31 stycznia 2028

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 sierpnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • VIR26001

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Participant data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future. Datasets will be de-identified to ensure patient privacy and confidentiality

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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