Urinary Tract Infections in ChildrenPhase 4FinNissleNCT04608851
Preventing Urinary Tract Infections With E. Coli Nissle:
A Phase 4 study testing E. coli Nissle in people with Urinary Tract Infections in Children and Secondary Prevention, run by University of Oulu at 5 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Urinary Tract Infections in Children, Secondary Prevention
- What is being tested?
- E. coli Nissle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 530 participants
- Where
- 5 sitesFinland
- Study dates
- 18 Jan 2021to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who suffer of the first urinary tract infection of their life defined as pyuria, presence of symptoms (fever or focal symptom), no other explanation for infection, bacterial culture positive or culture result pending
- Written informed consent
Who cannot join
- Preterm birth, gestational age less than 35 weeks
- Signs of life-threatening infection (such as meningitis)
- Detected anomaly in urinary tract
- Primary immunodeficiency
- Detected anomaly of GE tract
- Ongoing antimicrobial prophylaxis
- Hospital-acquired infection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites, 5 recruiting
- Not yet recruiting
Helsinki University Hospital
Helsinki, 00290
Harri Saxen, MD, PhD, harri.saxen@hus.fi
Tea Nieminen, MD, PhD
- Not yet recruiting
Kuopio University Hospital
Kuopio, 70210
Marjo Renko, MD, Phd, marjo.renko@uef.fi
Katri Backman, MD, PhD
- Recruiting
Department of Pediatrics, Oulu University Hospital
Oulu, 90014
Terhi Tapiainen, MD, PhD, +358-8-315 5185, terhi.tapiainen@oulu.fi
Niko Paalanne, MD, PhD, +358-8-315-8427, niko.paalanne@oulu.fi
- Not yet recruiting
Tampere University Hospital
Tampere, 33520
Merja Helminen, MD, PhD, merja.helminen@pshp.fi
Sari Törmänen, MD
- Not yet recruiting
Turku University Hospital
Turku, 20521
Ville Peltola, MD, PhD, ville.peltola@utu.fi
Lauri Ivaska, MD, PhD
About this study
Official title: Preventing Urinary Tract Infections in Infants and Young Children With Probiotic E. Coli Nissle:
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.
Read the detailed description
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.
- Being tested
- E. coli Nissle, Placebo control
- Keywords
- Urinary Tract Infections, E. coli
- Medical subject headings
- Urinary Tract Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli NissleDrug
Also called Mutaflor
1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain
Placebo controlOther
1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: E. coli Nissle |
| 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 Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of urinary tract infections
Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection
Measured: Six months from study entry
Secondary outcomes (6)
Number of urinary tract infections
Number of bacterial culture confirmed urinary tract infections per person years at risk (PYR)
Measured: Six months from study entry
Hospitalization day due to bacterial culture confirmed urinary tract infection
Number of days spent in the hospital during follow up
Measured: 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
Measured: 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
Measured: Six months from study entry
Diarrhea
Number of days with diarrhea reported by families during follow up at web-based survey
Measured: Six months from study entry
Antimicrobial treatment days for any indication
Number of days when study patient has received antimicrobial treatment
Measured: Six months, starting after the initial treatment at study entry has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start18 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blinded, Placebo controlled and randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Kuopio University Hospital, Tampere University Hospital, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Terhi Tapiainen, University of Oulu
- Investigators
- Terhi Tapiainen, MD, PhD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608851
- Sponsor's protocol ID
- OYS_Tapiainen_002
- Acronym
- FinNissle
- Status last verified
- Jul 2022
- First submitted
- 28 Oct 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared after reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Urinary Tract Infections in Infants and Young Children With Probiotic E. Coli Nissle:
- ClinicalTrials.gov ID
- NCT04608851
- Acronym / sponsor ID
- FinNissle / OYS_Tapiainen_002
- Keywords
- Urinary Tract Infections, E. coli
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Turku University Hospital, Kuopio University Hospital, Tampere University Hospital, Helsinki University Central Hospital
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blinded, Placebo controlled and randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Nissle group | Experimental | Drug: E. coli NissleIntervention 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 | Other: Placebo controlIntervention 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 |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who suffer of the first urinary tract infection of their life defined as pyuria, presence of symptoms (fever or focal symptom), no other explanation for infection, bacterial culture positive or culture result pending
- Written informed consent
Key exclusion criteria (7 listed)
- Preterm birth, gestational age less than 35 weeks
- Signs of life-threatening infection (such as meningitis)
- Detected anomaly in urinary tract
- Primary immunodeficiency
- Detected anomaly of GE tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E. coli NissleAlso: Mutaflor1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain | Drug | Nissle group |
| Placebo control1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g. | Other | Control group |
Primary outcome
Recurrence of urinary tract infections
Time frame: Six months from study entry
Proportion of the study patient who will have at least one bacterial culture confirmed urinary tract infection
6 secondary outcomes
Number of urinary tract infections
Time frame: Six months from study entry
Hospitalization day due to bacterial culture confirmed urinary tract infection
Time frame: Six months from study entry
Antimicrobial treatment days for suspected or confirmed urinary tract infection
Time frame: Six months, starting after the initial treatment at study entry has ended
Stomach pain
Time frame: Six months from study entry
Diarrhea
Time frame: Six months from study entry
Antimicrobial treatment days for any indication
Time frame: Six months, starting after the initial treatment at study entry has ended
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No. IPD will be shared after reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terhi Tapiainen, MD, PhD principal investigator
University of Oulu
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing E. coli Nissle in people with Urinary Tract Infections in Children and Secondary Prevention, run by University of Oulu at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terhi Tapiainen (+35883155185, terhi.tapiainen@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of urinary tract infections (time frame: Six months from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.