NL-OMON55745已完成不适用
Establishing an etiological role of the gut microbiome in the antiphospholipid syndrome phenotype - ROMAS study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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.
排除标准
- •- 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
研究者
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