The role of the gut MIcrobiota in the SyStemic Immune respONse during human endotoxemia

The role of the gut MIcrobiota in the SyStemic Immune respONse during human endotoxemia - MISSION-2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38933

Enrollment

Registered

2014-03-04

Start date

2014-04-16

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

All subjects will receive lipopolysaccharide intravenously (endotoxin

2 ng/kg body weight) to induce experimental endotoxemia. Eight subjects will be pretreated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days (washout period

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Healthy (medical history, no use of medication; normal physical examination, ECG and laboratory tests) 2. Male between 18 and 35 years of age 3. Normal defecation pattern

Exclusion criteria

Exclusion criteria: 1. Recent major illness or chronic medical illness 2. History of malignancy 3. Gastrointestinal and liver diseases 4. Known positive test for hepatitis B or C or HIV 5. Smoking; drug abuse; alcohol abuse 6. Clinically relevant ECG abnormality 7. Subject has received an investigational product within three months of day 1 of the current study 8. Use of prescription or non-prescription drugs 9. Recent (28 kg/m2

Design outcomes

Primary

Measure	Time frame
Laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation assay) and gut microbiota composition.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)