Dengue infection and intestinal permeability

Recruiting

• Conditions: Dengue infection patients and healthy volunteer who are 18-50 years old; dengue infection; lipopolysaccharide; intestinal permeability; cytokines

• Registration Number: TCTR20210208002
• Lead Sponsor: Department of Clinical Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Study Completion: 2021-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Participants diagnosed with dengue (by dengue antigen NS1 or PCR for dengue virus) with or without warning signs, fulfilling World Health Organization criteria and in-patient treatment, 2. No previous diagnosed dengue fever (by taking history), 3. Age 18-50 years old, 4. Normal consciousness without significant fatigue or dehydration, 5. No known any medical illness, no current medication taking (except acetaminophen will be allowed in patients with dengue infection group only), 6. Able to provide written informed consent.

Exclusion Criteria

1. Diagnosis of severe dengue infection, fulfilling World Health Organization criteria. Severe dengue infection is a potentially fatal complication, due to severe plasma leaking, severe fluid accumulation, respiratory distress, severe bleeding, or organ impairment, 2. Presence of comorbidities (e.g. pneumonia, diarrhea, diabetes, other local or systemic infections, cardiovascular or cerebrovascular or renovascular comorbidities, etc.) at time of admission, 3. Recent use of medication (except acetaminophen will be allowed in patients with dengue infection group only) or over the counter medication, prebiotic, probiotic or vitamin supplements, 4. History of gastrointestinal surgery, 5. Family history of inflammatory/irritable bowel syndrome, 6. Known to hypersensitivity reaction to mannitol and/or lactulose, 7. Presence of alcohol intake or substance misuse, 8. Pregnancy, 9. During menstruation period, 10. Non-Thai speaking participants.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal permeability Day +1 after admission and Day+7 of fever onset Urinary lactulose-mannitol ratio

Secondary Outcome Measures

Name	Time	Method
Intestinal damage and inflammation Day +1 after admission and Day+7 of fever onset Serum concentrations of human intestinal fatty acid binding protein (I-FABP); serum calprotectin; serum beta-D-glucan level,Blood microbiome Day +1 after admission and Day+7 of fever onset 16S rDNA high-throughput sequencing,Endotoxinemia Day +1 after admission and Day+7 of fever onset Endotoxin activity assay,Cytokine levels Day +1 after admission and Day+7 of fever onset Interleukin (IL)-1beta, IL-6, IL-8, tumor necrosis factor (TNF)-alpha, and CRP,Immune profiling Day +1 after admission and Day+7 of fever onset Direct immune profiling assay