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Gut Leakage' in Dengue (GLiD)

3 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

190

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Bengladesh
    • Chattogram Division
      • Chittagong, Chattogram Division, Bengladesh, 4203
        • Recrutement
        • Department of Medicine, Chittagong Medical College
        • Contact:
          • Rabiul Alam Md Erfan Uddin, FCPS
          • Numéro de téléphone: +8801711129798
          • E-mail: rubelerfan@gmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Level of gut leakage marker in blood and gastrointestinal findings in POCUS
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Document clinical events occurred in dengue patients
Délai: 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
Délai: Day of enrolment/ 4th or day 7 of illness

For mSOFA:

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

Autres mesures de résultats

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Oxford

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2026

Achèvement primaire (Estimé)

31 janvier 2027

Achèvement de l'étude (Estimé)

31 janvier 2028

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

15 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 août 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • VIR26001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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