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临床试验/NCT03421184
NCT03421184已完成不适用

Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2018年11月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Quantification of different isoflavones and enterolactone

研究概览

简要总结

The study aims at determining if dietary phytoestrogens can be risk factors for Systemic Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed in blood and urine of patients with SLE in an active phase of the disease, in patient with other autoimmune diseases and in healthy volunteers. Subjects will be premenopausal women and when possible at a define stage of the menstrual cycle. Free blood estradiol will be assayed as a confounding risk factor.

详细描述

SLE is a disease occurring in 90% of the cases in pre-menopausal women. The causing factors are largely unknown even though genetic and environmental factors have already been identified. Estrogens, on one side, have been shown to negatively influence the incidence and severity of the disease while testosterone and progesterone on the other side are thought to be protective. Endocrine disruptors can potentially influence the occurrence and severity of the disease. Among these disruptors, soy isoflavones which are ubiquitous in modern processed food are known to be estrogenic and anti-androgenic. Their depleting effect on luteinizing hormone (LH) secretion can also lead to progesterone plasma level impairments. For these reasons, estrogenic isoflavones, appear as potential environmental risk factors for SLE and its flares. Although some data exist in transgenic rodent, there is actually no clinical data in young women.

The study is an observational, monocentric, preliminary study aiming at determining if estrogenic isoflavones can be risk factors for SLE. No treatment is planned. The intervention will be the collection of extra blood and urine samples on SLE subjects and on autoimmune and healthy counterparts.

Consumers are unintentionally exposed to estrogenic isoflavones through their diet. A dietary habit enquiry and a 48h dietary recall (based on pharmacokinetics of soy-isoflavones) will be proposed to the included subjects. Urine and blood samples collected during a clinical visit performed 7 days after the onset of previous menses will be analyzed for soy isoflavones, metabolites and for enterolactone both free and conjugated. Free estradiol will be assayed as a potential confounding risk factor.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Group : Systemic Lupus Erythematosus :
  • Premenopausal women over 18
  • with acute LEAD flare
  • having given informed consent
  • and being covered by social insurance.
  • Group : Autoimmune diseases :
  • Premenopausal women of matching age with other autoimmune disease,
  • having given informed consent
  • and being covered by social insurance.
  • Healthy controls :
  • Premenopausal women over 18,
  • having given informed consent,
  • and being covered by social insurance.

排除标准

  • Group Systemic Lupus Erythematosus and group autoimmune diseases
  • Human Immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis C virus (HBV) sero-positivity;
  • pregnant or lactating women;
  • menopausal women;
  • patient in remission of quiescent phase of her pathology;
  • Healthy controls :
  • HIV, HCV or HBV sero-positivity;
  • pregnant or lactating women;
  • menopausal women.

研究组 & 干预措施

Healthy control

Active Comparator

30 healthy control women

干预措施: urine sample (Other)

Healthy control

Active Comparator

30 healthy control women

干预措施: blood sample (Other)

Patient with Systemic Lupus Erythematosus

Experimental

30 women with SLE

干预措施: blood sample (Other)

Patient with Systemic Lupus Erythematosus

Experimental

30 women with SLE

干预措施: urine sample (Other)

Patient with Systemic Lupus Erythematosus

Experimental

30 women with SLE

干预措施: food questionnaire (Other)

Patients with other autoimmune diseases

Active Comparator

20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia

干预措施: urine sample (Other)

Patients with other autoimmune diseases

Active Comparator

20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia

干预措施: blood sample (Other)

Patients with other autoimmune diseases

Active Comparator

20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia

干预措施: food questionnaire (Other)

Patient with Systemic Lupus Erythematosus

Experimental

30 women with SLE

干预措施: hair (Other)

Patients with other autoimmune diseases

Active Comparator

20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia

干预措施: hair (Other)

Healthy control

Active Comparator

30 healthy control women

干预措施: hair (Other)

Healthy control

Active Comparator

30 healthy control women

干预措施: food questionnaire (Other)

结局指标

主要结局

Quantification of different isoflavones and enterolactone

时间窗: At baseline (day 0)

in the blood and urine of patients and healthy controls

次要结局

  • Quantification of free estradiol concentrations(At baseline (day 0))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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