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GUTDVT trial.

Bi-directional crosstalk between gut and endothelium in development of DVT via specific deficiencies in (vitamin K synthesizing) gram negative gut microbiota.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26347
Enrollment
20
Registered
2011-02-21
Start date
2011-01-01
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

subject with suspected Deep Venous Thrombosis (DVT)

Interventions

Acenocoumarol in subjects with proven DVT according to current guidelines.

Sponsors

AMC-UvA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males or postmenopausal females; 2. Age between 18 and 60 years; 3. Suspicion of DVT at time of inclusion; 4. Written informed consent for future evaluation at time of diagnosis; 5. Fasted (no meal, coffee or tea) for at least 3 hours.

Exclusion criteria

Exclusion criteria: 1. Smoking > 5 sig/day; 2. Premenopauzal females (due to hormonal changes); 3. Patients any medication including oral antionceptives and PPIs; 4. Use of antibiotics in last 3 months.

Design outcomes

Primary

MeasureTime frame
Changes in fecal flora/gutmicrobiota (HITCHIP see Qin Nature 2010) analysis of 1200 known intestinal bacteria in subjects with DVT vs subjects with a clinical suspicion of DVT but the absence of this diagnosis.

Secondary

MeasureTime frame
Associations between gutmicrobiota changes (HITCHIP), plasma levels of coagulation (Endogenous thrombin potential) and endothelial gycocalyx metabolism (SDF sublingual imaging and plasma hyaluronan and heparansulphate by ELISA).

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)