Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Turku University Hospital | OTHER_GOV |
| Kuopio University Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Helsinki University Central Hospital |
Not provided
Not provided
Not provided
Not provided
Urinary tract infections (UTIs) account for 5-14% of pediatric emergency department visits annually. At the moment, up to one third of children suffering of acute (UTI) will have a new infection and there is a lack of effective methods for preventing secondary UTIs in young children. Majority of UTIs in children are caused by intestinal bacteria of the patient, mainly E. coli that colonizes gut of the patient. E. coli Nissle is a probiotic strain that has been used successfully for treating acute gastrointestinal infections in children. The strain has also been proved to be safe for infants and young children. E. coli Nissle could be a potential solution for preventing recurrent urinary tract infections in children as it competes with pathogenic bacteria that usually cause UTIs in children.
The aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.
In order to asses efficacy of E. coli Nissle strain in prevention of recurrent UTIs in children, we aim to conduct randomized, placebo controlled and double blinded clinical trial. We are going to recruit children who are suffering the first urinary tract infection of their life. The UTI will be treated by normal clinical recommendations decided by treating physician. Intervention will start on the day following the last day of the antimicrobial course.
The intervention will last for 15 days and the study participants will receive either intervention drug or placebo. Intervention drug contains 10 E8 CFU/ml of E. coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year.
The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up. We are also going to record possible adverse effects in both study groups. Also use of antimicrobial medication due to any reason will be recorded.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nissle group | Experimental | Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral suspension containing 10 E8 CFU/ml of E coli Nissle. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days |
|
| Control group | Placebo Comparator | Intervention will start on the day following the ending of the antimicrobial treatment of the UTI. Patients will receive 1 ml of oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g. Patients under one year of age will receive one daily dose and patients aged more than one year will receive a dose twice daily. Intervention will last for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E. coli Nissle | Drug | 1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of urinary tract infections | Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection | Six months from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Number of urinary tract infections | Number of bacterial culture confirmed urinary tract infections per person years at risk (PYR) | Six months from study entry |
| Hospitalization day due to bacterial culture confirmed urinary tract infection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Terhi Tapiainen | Contact | +35883155185 | terhi.tapiainen@oulu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Terhi Tapiainen, MD, PhD | University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Not yet recruiting | Helsinki | 00290 | Finland |
IPD will be shared after reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| OTHER |
Double Blinded, Placebo controlled and randomized clinical trial
Not provided
Not provided
The intervention drug or placebo will be given to participants in closed boxes without any labels. Appearance and dosing of the products will be similar. Investigators will not handle the boxes or study products.
| Placebo control | Other | 1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g. |
|
Number of days spent in the hospital during follow up
| Six months from study entry |
| Antimicrobial treatment days for suspected or confirmed urinary tract infection | Number of days when study patient has received antimicrobial treatment | Six months, starting after the initial treatment at study entry has ended |
| Stomach pain | Number of days with stomach pain reported by families during follow up at web-based surveys | Six months from study entry |
| Diarrhea | Number of days with diarrhea reported by families during follow up at web-based survey | Six months from study entry |
| Antimicrobial treatment days for any indication | Number of days when study patient has received antimicrobial treatment | Six months, starting after the initial treatment at study entry has ended |
| Kuopio University Hospital | Not yet recruiting | Kuopio | 70210 | Finland |
|
| Department of Pediatrics, Oulu University Hospital | Recruiting | Oulu | 90014 | Finland |
|
| Tampere University Hospital | Not yet recruiting | Tampere | 33520 | Finland |
|
| Turku University Hospital | Not yet recruiting | Turku | 20521 | Finland |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |