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Urinary tract infections affect more than 130 million people worldwide each year. Almost 50% of women will have at least one urinary tract infection during their lifetime, usually cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment for cystitis, but their effectiveness is decreasing due to the rapid spread of multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more specifically innate immunity cells, play a key role in controlling urinary tract infections. In addition, clinical studies have shown that there is a high inter-individual variability in the ability of innate immune cells to respond to different stimuli. We therefore hypothesized that there was an association between the risk of recurrent cystitis and a deficiency of certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α, in response to one or more bacterial stimuli, particularly flagellin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No recurrent UTI | Experimental | Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years |
|
| Recurrent UTI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of blood samples | Procedure | 23 mL of blood will be collected during the inclusion visit |
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| Measure | Description | Time Frame |
|---|---|---|
| TNF-α measurement in blood cell culture media using Luminex® technology. | The concentrations of TNF-α will be expressed in ng/ml by calibration with a standard range. | At 18 months |
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Inclusion Criteria:
Exclusion Criteria:
Subject protected by law under guardianship or curatorship, or unable to participate in a clinical study under Article L. 1121-16 of the French Public Health Code;
Subject who has participated in a clinical research study in the last 3 months in which he/she was exposed to a pharmaceutical product or medical device;
Subject who has stayed in a tropical or subtropical country in the last 3 months;
Pregnant or breastfeeding subject for women of childbearing age;
Subject with special diet for medical reasons and prescribed by a doctor or dietician (e.g. a low-calorie diet or a diet intended to lower cholesterol levels);
Subject who regularly consumes large quantities of alcohol, i. e. more than 50 g of pure alcohol per day (e. g. more than 4 glasses of 150 ml wine, more than 4 pints of 250 ml beer, or more than 4 glasses of 40 ml containing strong alcohol);
Subject who has used an illegal recreational drug in the past 3 months;
Subject who has taken an immunosuppressive or immunomodulatory drug (excluding intranasally or topically administered corticosteroids) in the past 2 weeks, or for more than 14 consecutive days in the past 6 months;
Subject who has been vaccinated within the last 3 months;
Subject who received a blood transfusion or immunoglobulins in the last 3 months;
Subject stating that he has not been fasting for at least 10 hours;
Subject reporting HIV or HCV status;
Subject who had an infectious episode or was treated with antibiotics during the 4 weeks prior to the visit;
Subject with a positive urinary pregnancy test;
Subject with a severe and/or chronic and/or recurrent pathology, in particular:
Subject who has been diagnosed with cancer and has not been in remission for more than 5 years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie | Nice | 06200 | France |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Collection of fecal samples | Other | Fecal sample self-collected after the inclusion visit |
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| Collection of urine samples | Other | 10 mL of urine will be collected during the inclusion visit |
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| Collection of vaginal swaps | Other | Sample of vaginal microbiota collected during the inclusion visit |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |