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NCT Number: NCT07602920

Gut Leakage' in Dengue

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.

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Key information

Conditions

Dengue Arbovirus Infections Ascites Dengue Hemorrhagic Fever Dengue With Warning Signs Digestive System Diseases Flaviviridae Infections Flavivirus Infections Gastrointestinal Diseases Gut Microbiome Hemorrhagic Fevers, Viral Infections Intestinal Disease Intestinal Diseases Mosquito-Borne Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Severe Dengue Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine, Chittagong Medical College

Chittagong, Chattogram Division, 4203, Bangladesh

Location contact

Rabiul Alam Md Erfan Uddin, FCPS

CONTACT

[email protected]

+8801711129798

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Level of gut leakage marker in blood and gastrointestinal findings in POCUS

    Time frame: On enrollment, day of development of severity if non severe at enrolment, up to 28 days

Secondary outcomes

  1. Document clinical events occurred in dengue patients

    Time frame: 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

  2. Document clinical events occurred in dengue patients

    Time frame: Day of enrolment/ 4th or day 7 of illness

    For mSOFA:

    SpO2, FiO2

Other outcomes

  1. Level of I-FABP Level of LPS, Level of LBP, Level of sCD14, Positive Blood culture

    Time frame: On enrollment in all cases, if clinical severity occur in initial non-severe group, 24 hours within developing severity

  2. Detectable fluid collection in abdomen, loss of haustration, loss of normal multi-layered appearance

    Time frame: 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.

  3. Measurement of gall bladder wall thickness, intestinal wall thickness

    Time frame: 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.

  4. Alteration of gut microbiota

    Time frame: Day seven of illness

  5. Organ failure

    Time frame: Through study completion, an average of 28 day

  6. Development of shock

    Time frame: Through study completion, an average of 28 day

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Gut Leakage and Sonographic Abdominal Changes in Hospitalized Dengue Patients: an Observational Study

Acronym: GLiD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 22, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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