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The effects of vancomycin on gut bacteria and coagulation values in the blood.

Effects of oral vancomycin on the gut microbiome and coagulation parameters in healthy and obese volunteers. The GRIEG study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20609
Enrollment
40
Registered
2015-03-11
Start date
2015-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Venous thrombosis, gut microbiome, antibiotics, coagulation, complement, obesity.

Interventions

Orally applied Vancomycin 500mg 3 times daily for 7 days.

Sponsors

The Arctic University of Norway, Tromsø, department of Clinical Medicine, TREC (Thrombosis Research and Expertise Center), Farmasibygget, 9037 Tromsø, Norge.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Eighteen years of age or older - Not older than 40 years - Comprehension of English or Norwegian language - Lean bodymass (n=20) - BMI >=27kg/m2, (n=20)

Exclusion criteria

Exclusion criteria: - The use of any medication during the last month before the start of the study until the end of the study period (including oral contraceptives) - Being post-partum or having used the contraceptive pill during the last 3 months before the study - The use of anti-, probiotics (Idoform Classic Plus) in the 2 months before the study - Pregnancy in women (a pregnancy test will be offered to all participating women) - Known chronic medical inflammatory conditions including inflammatory bowel diseases, rheumatic diseases, diabetes mellitus and HIV-infection - Recent history of illness 2x upper limit of normal - Any current feverish episode at day -7 (T>37.5 degrees Celsius)

Design outcomes

Primary

MeasureTime frame
Factor VIII (FVIII:C)

Secondary

MeasureTime frame
Individual coagulation parameters Parameters of inflammation (hs-CRP, TNF-alpha) Lipopolysaccharids in plasma Complement activity Changes in composition of the gut microbiome

Contacts

Public ContactVladimir Tichelaar

UMC Groningen - Hematologie - HP AA24

y.tichelaar@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)