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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02679-44 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with Systemic Lupus Erythematosus | Experimental | 30 women with SLE |
|
| Patients with other autoimmune diseases | Active Comparator | 20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia |
|
| Healthy control | Active Comparator | 30 healthy control women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Other | 25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of different isoflavones and enterolactone | in the blood and urine of patients and healthy controls | At baseline (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of free estradiol concentrations | in the blood and urine of patients and healthy controls | At baseline (day 0) |
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Inclusion Criteria:
Group : Systemic Lupus Erythematosus :
Group : Autoimmune diseases :
Healthy controls :
Exclusion Criteria:
Group Systemic Lupus Erythematosus and group autoimmune diseases
Healthy controls :
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François VIALLARD, Prof | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - service de médecine interne | Pessac | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36079877 | Result | Bensaada S, Raymond I, Breton M, Pellegrin I, Viallard JF, Bennetau-Pelissero C. Development of an Assay for Soy Isoflavones in Women's Hair. Nutrients. 2022 Sep 1;14(17):3619. doi: 10.3390/nu14173619. | |
| 36839324 | Result | Bensaada S, Raymond I, Pellegrin I, Viallard JF, Bennetau-Pelissero C. Validation of ELISAs for Isoflavones and Enterolactone for Phytoestrogen Intake Assessment in the French Population. Nutrients. 2023 Feb 15;15(4):967. doi: 10.3390/nu15040967. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| urine sample | Other | 10 ml |
|
| food questionnaire | Other | dietary habit enquiry and a 48h dietary |
|
| hair | Other | lock of hair |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |