antiphospholipid syndrome
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the revised Sapporo classification criteria for antiphospholipid syndrome: At least one of the clinical and at least one of the laboratory criteria below Clinical criteria 1. Thrombosis One or more clinical episodes of arterial, venous, or small vessel thrombosis, in any tissue or organ. Thrombosis must be confirmed by objective validated criteria (i.e., unequivocal findings of appropriate imaging studies or histopathology). 2. Pregnancy morbidity (a) One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, with normal fetal morphology documented by ultrasound or by direct examination of the fetus, or (b) One or more premature births of a morphologically normal neonate before the 34th week of gestation because of: (i) eclampsia or severe pre-eclampsia de*ned according to standard de*nitions, or (ii) recognized features of placental insu*ciency*,or (c) Three or more unexplained consecutive spontaneous abortions before the 10th week of gestation, with maternal anatomic or hormonal abnormalities and paternal and maternal chromosomal causes excluded. Laboratory criteria a Lupus anticoagulant (LA) present in plasma, on two or more occasions at least 12 weeks apart, detected according to the guidelines of the International Society on Thrombosis and Haemostasis (Scienti*c Subcommittee on LAs/phospholipid-dependent antibodies). b. Anticardiolipin (aCL) antibody of IgG and/or IgM isotype in serum or plasma, present in medium or high titer (i.e. >40 GPL or MPL, or >the 99th percentile), on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA. c. Anti-b2glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma (in titer >the 99th percentile), present on two or more occasions, at least 12 weeks apart, measured by a standardized ELISA, according to recommended procedures.
Exclusion criteria
Exclusion criteria: - Age below 18 years - Current use of antibiotics - History of gastro-enteritis in the past month - History of inflammatory bowel disease - Current use of a vitamine K antagonist - Planned change in the following medication during the study period (either start, stop or dose change): platelet aggregation inhibitors, oral anticoagulants, heparins, hormonal therapy. - Current pregnancy or pregnancy in the past 6 weeks - Arterial or venous thrombosis in the past month - Allergy to vancomycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study outcome is the composite of a broad panel of APS pathophysiology-related blood biomarkers. These biomarkers are regarded to collectively reflect the APS phenotype. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is gut permeability as measured by lactulose/mannitol test. | — |
Countries
Netherlands
Outcome results
None listed