Predict-UTI: Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: No recurrent UTI Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years |
Procedure: Collection of blood samples
23 mL of blood will be collected during the inclusion visit
Other: Collection of fecal samples
Fecal sample self-collected after the inclusion visit
Other: Collection of urine samples
10 mL of urine will be collected during the inclusion visit
Other: Collection of vaginal swaps
Sample of vaginal microbiota collected during the inclusion visit
|
| Experimental: Recurrent UTI
|
Procedure: Collection of blood samples
23 mL of blood will be collected during the inclusion visit
Other: Collection of fecal samples
Fecal sample self-collected after the inclusion visit
Other: Collection of urine samples
10 mL of urine will be collected during the inclusion visit
Other: Collection of vaginal swaps
Sample of vaginal microbiota collected during the inclusion visit
|
Outcome Measures
Primary Outcome Measures
- TNF-α measurement in blood cell culture media using Luminex® technology. [At 18 months]
The concentrations of TNF-α will be expressed in ng/ml by calibration with a standard range.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female aged 18 to 28 years;
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Subject accepting to be serologically tested for HIV and HCV;
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Subject considered healthy by the physician on the basis of medical history and clinical examination;
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Subject with a body mass index between 18.5 and 30 kg/m2;
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Subject understands and speaks French and is able to give written consent;
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Subject affiliated to Social Security or a similar regime;
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Having reported a single cystitis since the age of 14 (Group 1), or 3 or more cystitis over a 12-month period since the age of 14 (Group 2).
Exclusion Criteria:
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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;
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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;
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Subject who has stayed in a tropical or subtropical country in the last 3 months;
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Pregnant or breastfeeding subject for women of childbearing age;
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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);
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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);
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Subject who has used an illegal recreational drug in the past 3 months;
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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;
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Subject who has been vaccinated within the last 3 months;
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Subject who received a blood transfusion or immunoglobulins in the last 3 months;
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Subject stating that he has not been fasting for at least 10 hours;
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Subject reporting HIV or HCV status;
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Subject who had an infectious episode or was treated with antibiotics during the 4 weeks prior to the visit;
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Subject with a positive urinary pregnancy test;
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Subject with a severe and/or chronic and/or recurrent pathology, in particular:
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A chronic inflammatory and/or autoimmune or allergic disease and in particular a chronic inflammatory disease of the intestine (Crohn's disease, ulcerative colitis), epidermis (psoriasis, atopic dermatitis), joints (rheumatoid arthritis), nervous system (multiple sclerosis), type I diabetes;
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High blood pressure or type II diabetes;
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A neurodegenerative disease.
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Subject who has been diagnosed with cancer and has not been in remission for more than 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie | Nice | France | 06200 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-PP-05