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ID
Source
Brief title
Health condition
Obstetric antiphospholipid syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the composite of a broad panel of APS pathophysiology-related blood biomarkers. These biomarkers are regarded to collectively reflect the oAPS phenotype.
Secondary outcome
Gut permeability measured by lactulose/mannitol test.
Reduction in antiphospholipid antibodiy titers
Subgroup analysis of severe phenotype patients, based on clinical manifestations and antibody profiles
Background summary
The ROMAS study aims to establish proof-of-concept for an etiological role of the gut microbiome in human obstetric antiphospholipid syndrome. The study has a pretest-posttest design in which all subjects undergo a 7 day course of oral vancomycin. The primary study outcome is the composite of a broad panel of APS pathophysiology-related blood biomarkers.
Study objective
We aim to establish proof-of-concept for an etiological role of the gut microbiome in human oAPS and further hypothesize that this is mediated by increased intestinal permeability.
Study design
Day -8, 0, 8, 42
Intervention
All subjects will undergo a 7 day treatment course of oral vancomycin, 500mg 4 times daily, a standard antibiotic.
Inclusion criteria
Obstetric APS diagnosed by Sydney criteria:
1. A history of one or more of the following forms of 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 defined according to standard definitions, or (ii) recognized features of placental insufficiency–,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.
2. A history of one or more of the following 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 (Scientific 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
- Age below 18 years
- Current use of antibiotics
- History of gastro-enteritis in the past month
- History of inflammatory bowel disease
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7662 |
| Other | METC Academic Medical Center Amsterdam : METC2018_288 |