Clinical study to investigate the mode of action of Uro-Vaxom® in women suffering from recurrent urinary tract infections

Pilot study to investigate the mode of action (MoA) of Uro-Vaxom® on a molecular level in pre-menopausal women suffering from recurrent urinary tract infections (rUTI) - OM-89 Modes of action study in women with recurrent UTI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004961-14-SE

Enrollment

Registered

2014-04-29

Start date

2014-06-11

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent urinary tract infections (rUTI) MedDRA version: 17.0 Level: LLT Classification code 10038140 Term: Recurrent urinary tract infection System Organ Class: 100000004862

Interventions

Trade Name: Uro-Vaxom Pharmaceutical Form: Capsule INN or Proposed INN: lyophilised Escherichia coli bacterial lysate Other descriptive name: LYOPHILISED ESCHERICHIA COLI BACTERIAL LYSATE Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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). ;Secondary Objective: 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. ;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.;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	—

Measure

Time frame

Main Objective: 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). ;Secondary Objective: 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. ;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.;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

—

Secondary

Measure	Time frame
Secondary end point(s): Gene expression and proteomics in kidney and uro-epithelial cells.;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Sweden

Contacts

Public ContactMD Björn Wullt

Kliniken Kärnan Urology Centre

bjorn.wullt@med.lu.se+46708991956

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026