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Gut Leakage' in Dengue (GLiD)

3. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

190

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Bangladesh
    • Chattogram Division
      • Chittagong, Chattogram Division, Bangladesh, 4203
        • Rekruttering
        • Department of Medicine, Chittagong Medical College
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Level of gut leakage marker in blood and gastrointestinal findings in POCUS
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Document clinical events occurred in dengue patients
Tidsramme: 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
Tidsramme: Day of enrolment/ 4th or day 7 of illness

For mSOFA:

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

Andre resultatmål

Resultatmål
Tidsramme
Level of I-FABP Level of LPS, Level of LBP, Level of sCD14, Positive Blood culture
Tidsramme: 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
Tidsramme: Day seven of illness
Day seven of illness
Organ failure
Tidsramme: Through study completion, an average of 28 day
Through study completion, an average of 28 day
Development of shock
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Oxford

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2026

Primær fullføring (Antatt)

31. januar 2027

Studiet fullført (Antatt)

31. januar 2028

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

15. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VIR26001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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