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Dengue danger linked to leaky gut? new study investigates

NCT ID NCT07602920

Knowledge-focused Sponsor: University of Oxford Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This observational study will enroll 190 hospitalized adults with dengue in Bangladesh to see if a 'leaky gut' — where bacteria and toxins escape the intestines into the blood — is linked to severe disease. Researchers will measure gut leakage markers in blood, perform abdominal ultrasounds, and analyze gut bacteria from stool samples. The goal is to understand how gut problems might make dengue worse, but this study does not test any treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how gut leakage contributes to severe dengue, pointing toward new ways to predict or prevent life-threatening complications.
What could go wrong
This is an early observational study, not a treatment trial. It may find no clear link between gut leakage and disease severity, and results may not apply to all dengue patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Ascites dengue disease Dengue hemorrhagic fever dengue shock syndrome intestinal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ascites Dengue Dengue hemorrhagic fever Dengue with warning signs Gut microbiome Intestinal disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Medicine, Chittagong Medical College

    RECRUITING

    Chittagong, Chattogram Division, 4203, Bangladesh

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Other studies related to the condition(s) this trial covers.