E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent urinary tract infections (rUTI) |
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E.1.1.1 | Medical condition in easily understood language |
Recurrent urinary tract infections (rUTI) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038140 |
E.1.2 | Term | Recurrent urinary tract infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1) Provide an overview of the host-susceptibility gene repertoire in patients with rUTI via DNA sequencing.
2) Determine the molecular effects of OM-89 in patients with rUTI receiving OM-89 (according to the registered posology of one capsule daily) for 3 months (90 days), followed by a 3-month wash-out period by investigating over time the following:
- gene expression analysis based on whole genome transcriptomics. This is expected to provide an unbiased overview of the response to OM-89 in the patients
- and proteomic analysis. This will screen the samples for cytokines involved in innate and specific immune responses to UTI (about 40 different cytokines, including innate immunity, B cell and T cell cytokines). |
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E.2.2 | Secondary objectives of the trial |
3) Investigate the host response to OM-89 at the molecular level in human cells. The aim of the in vitro study is to examine the effects of the polylysate OM-89 on gene expression and proteomics in kidney and uro-epithelial cells. Specific human cell lines will be therefore challenged with OM-89 extracts provided by OM Pharma. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Otherwise healthy pre-menopausal females who are naïve to OM-89 prophylaxis (>18 years old) suffering from recurrent non-febrile lower UTI (≥3 UTIs in previous year. UTI episodes should be documented by repeated cultures and at least 2 clinical symptoms and there should be a minimum interval of 2 weeks between each infection episode). |
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E.4 | Principal exclusion criteria |
- Diabetes mellitus type 1
- Poorly controlled diabetes mellitus type 2
- Treatment of malignant diseases in the past two years
- Corticosteroid treatment
- Auto-immune disorders
- Immune deficiency or immune compromised conditions
- Multiple sclerosis
- Women: pregnant or intending to be pregnant and not using acceptable contraceptives, menopausal status
- Previous OM-89 treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Gene expression analysis based on whole genome transcriptomics.
- Proteomic analysis to screen the samples for cytokines involved in innate and specific responses to UTI. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Visit 1: - 2 weeks
Visit 2: - 1 week
Visit 3 (0): Day 0
Visit 3 (3h): 3 hours after OM 89 intake
Visit 3 (24h): 24 hours after OM 89 intake
Visit 3 (48 h): 48 hours after OM89 intake
Visit 4: 10 days after OM 89 intake
Visit 5: 2 months after OM 89 intake
Visit 6: 3 months after OM 89 intake
Visit 7: 6 months after OM 89 intake
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E.5.2 | Secondary end point(s) |
Gene expression and proteomics in kidney and uro-epithelial cells. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Mode of action study on molecular level. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |