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

Completed

• Conditions: sepsis; 10019815

• Registration Number: NL-OMON38933
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

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 (< 12 months) use of antibiotics
10. Allergy to antibiotics
11. Difficultly in donating blood or limitied accessibility of a vein in left or right arm.
12. Subject has donated more than 350 mL of blood in last 3 months
13. Difficulty swallowing pills
14. Body mass index >28 kg/m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Laboratory parameters for inflammatory responses, functional assays (ex vivo<br /><br>stimulation assay) and gut microbiota composition.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>