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van CCT (UK)

van CCT (UK)

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

- candidate number21788
- NTR NumberNTR5093
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2015
- Secondary IDsUiT-TREC-2015-GRIEG EudraCT: 2015-001262-25
- Public TitleThe effects of vancomycin on gut bacteria and coagulation values in the blood.
- Scientific TitleEffects of oral vancomycin on the gut microbiome and coagulation parameters in healthy and obese volunteers. The GRIEG study.
- hypothesisRecently, (changes in) the gut microbiome (flora / bacteria) have been associated with obesity and insulin resistance, and other cardiovascular risk factors or atherogenic processes. Venous thrombosis shares these risk factors, probably by a shared low-grade inflammatory profile. This low-grade inflammation may partially be caused by changes in the composition of the gut microbiome or shifts in absolute numbers or abundance of phyli or species of bacteria. This in turn may lead to an increase of gut leakage and to an increased production of lipopolysaccharids (pieces of the outer membrane of gram-negative bacteria) that enter the bloodstream. Consequently a low grade inflammation is present, causing activation of the coagulation system.
Changes in the gut microbiome can be caused by dietary influences, antibiotics and probiotics among other (partially unknown) causes.

We hypothesize that changes in the microbiome of the gut by application of oral vancomycin might increase systemic metabolic endotoxemia in healthy lean volunteers, consequently creating a pro-coagulant state, marked by increased levels of factor VIII, d-dimer, TF+ monocytes and increased thrombin generation and a reduced fibrinolytic system (expressed as a increased clot lysis time), probably caused by increased levels of plasminogen activator inhibitor (PAI). Also, the classical pathway of the complement system might be more activated after the vancomycin challenge. In obese volunteers, one might speculate that the microbiome will change more towards a normal pattern (more alike to baseline [untreated] values of the lean volunteers) but this might be the other way around according to other literature. However, comparing baseline coagulation parameters of obese with non-obese volunteers, we expect to find that obese volunteers having a pro-coagulant and low-grade inflammatory state, with a changed Firmicutes/Bacteriodetes ratio.
- Healt Condition(s) or Problem(s) studiedVenous thrombosis, Gut microbiota, Antibiotics, Coagulation, Complement
- 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- 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 <1 month with involvement of the gastro-intestinal tract
- A history of irritable bowel disease
- Allergy for vancomycin or teicoplanin
- Kidney diseases or reduced kidney function (eGFR <60ml/min)
- Liver disease or known elevated GGT or ALAT >2x upper limit of normal
- Any current feverish episode at day -7 (T>37.5 degrees Celsius)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate30-sep-2015
- Target number of participants40
- InterventionsOrally applied Vancomycin 500mg 3 times daily for 7 days.
- Primary outcomeFactor VIII (FVIII:C)
- Secondary outcomeIndividual coagulation parameters
Parameters of inflammation (hs-CRP, TNF-alpha)
Lipopolysaccharids in plasma
Complement activity
Changes in composition of the gut microbiome
- TimepointsOutcomes will be assessed at baseline, at 2 days and 23 days after the intervention.
- Trial web site
- statusstopped: trial finished
- Sponsor/Initiator The Arctic University of Norway - department of Clinical Medicine, TREC (Thrombosis Research and Expertise Center)
- Funding
(Source(s) of Monetary or Material Support)
K.G. Jebsen Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-mrt-2015 - 3-mrt-2018

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