Viewing Study NCT04846803



Ignite Creation Date: 2024-05-06 @ 4:02 PM
Last Modification Date: 2024-10-26 @ 2:02 PM
Study NCT ID: NCT04846803
Status: RECRUITING
Last Update Posted: 2024-01-23
First Post: 2021-04-12

Brief Title: Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
Sponsor: Odense University Hospital
Organization: Odense University Hospital

Study Overview

Official Title: Bacterial Interference for Preventing Recurrent Urinary Tract Infection - New Ways of Treatment
Status: RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BIrUTI
Brief Summary: Urinary tract infection UTI is one of the most common bacterial infections worldwide It affects 150 million people annually Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs With this protocol we want to elucidate alternative treatment methods for especially recurrent urinary tract infection Bacteria have internal competitiveness bacterial interference and it is known that the non-pathogenic Ecoli can outcompete the pathogenic Ecoli in laboratory studies

We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical placebo-controlled double-blind trial at Odense University Hospital
Detailed Description: Urinary tract infection UTI is one of the most common bacterial infections worldwide It affects 150 million people annually Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs With this protocol we want to elucidate alternative treatment methods for especially recurrent urinary tract infection Bacteria have internal competitiveness bacterial interference and it is known that the non-pathogenic Ecoli can outcompete the pathogenic Ecoli in laboratory studies

We intend to strengthen the clinical evidence that it can be used as patient treatment through a clinical placebo-controlled double-blind trial at Odense University Hospital

Claim to be investigated

The non-pathogenic bacterial strain ABU Ecoli can overcome the most common pathogenic Ecoli UPEC in humans
ABU can be used for preventive treatment in patients with recurrent urinary tract infections

Clinical effect of preventive treatment prophylactic treatment with the non-pathogenic bacterial strain ABU in a selected group of patients with recurrent cystitis A clinical placebo-controlled triple-blinded study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None