Prevention of Urinary Tract Infections in ChildrenNCT03462160
Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
A study testing Probiotic experimental group in people with Prevention of Urinary Tract Infections in Children, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Prevention of Urinary Tract Infections in Children
- What is being tested?
- Probiotic experimental group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2018to 1 Sep 2019
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls
- ≥1 episode of urinary tract infection in the last 6 months
Who cannot join
- intake of probiotic preparations for ≥1 month in the last 3 months
- known allergy to the study products
- immunosuppression therapy
- disease with immune deficiency
- children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
Trial locations and contacts
1 site in 1 country.
Poland1 site
Children's Hospital for The Medical University of Warsaw
Warsaw, 02-091
About this study
Official title: Effectiveness of Prophylaxis of Urinary Tract Infections in Children With a Probiotic Containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1, a Randomised Clinical Trial
The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo.
Read the detailed description
In previously published European and global guidelines, there has been no consensus among experts regarding the prophylaxis of recurrence urinary tract infections. Depending on the recommendation, the prevention of recurrence UTI should be used, not justified, or should be used in special cases. However, preparations that will be effective in preventing UTI and will not cause bacterial resistance are still sought.
106 patients aged 3 to 18 years with recurrence UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) or children with ≥1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-days prophylaxsis arm (probiotic UroLact containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1) or a 90-days placebo arms.
The primary outcome measure will be frequencies of recurrence of UTI during the 6 months after the intervention.
- Being tested
- Placebo control group, Probiotic experimental group
- Keywords
- Urinary Tract Infection, prophylaxis, probiotics
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo control groupOther
Placebo will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal. The placebo appearance will be similar to the probiotic.
Probiotic experimental groupDietary supplement
Probiotic UroLact containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal.
| Study group | Role | What they receive |
|---|---|---|
| Placebo supply for 90 days | Placebo comparator | Patients will receive placebo (in blinded sachets) Receives: Other: Placebo control group |
| Probiotic supply for 90 days | Experimental | Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets). Receives: Dietary Supplement: Probiotic experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequencies of recurrence of UTI
New onset of symptomatic UTI within the 6 months follow-up period.
Measured: 6 months after intervention
Secondary outcomes (2)
frequencies of hospitalization due to UTI
Measured: 6 months after intervention
the number of days of antibiotic therapy due to UTI
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prevention of Urinary Tract Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Miralex Sp. z o.o.
- Responsible party
- Sponsor
- Investigators
- Malgorzata Panczyk-Tomaszewska, Assistant Professor, Study chair, Medical University of WarsawMaria Daniel, MD, Principal investigator, Medical University of WarsawHanna Szymanik-Grzelak, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462160
- Sponsor's protocol ID
- UTI probiotic
- Status last verified
- Feb 2018
- First submitted
- 28 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tewary K, Narchi H. Recurrent urinary tract infections in children: Preventive interventions other than prophylactic antibiotics. World J Methodol. 2015 Jun 26;5(2):13-9. doi: 10.5662/wjm.v5.i2.13. eCollection 2015 Jun 26.
PubMed 26140267Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.
PubMed 26695595Hosseini M, Yousefifard M, Ataei N, Oraii A, Mirzay Razaz J, Izadi A. The efficacy of probiotics in prevention of urinary tract infection in children: A systematic review and meta-analysis. J Pediatr Urol. 2017 Dec;13(6):581-591. doi: 10.1016/j.jpurol.2017.08.018. Epub 2017 Oct 9.
PubMed 29102297Daniel M, Szymanik-Grzelak H, Turczyn A, Panczyk-Tomaszewska M. Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial. BMC Urol. 2020 Oct 23;20(1):168. doi: 10.1186/s12894-020-00723-1.
PubMed 33097017
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prophylaxis of Urinary Tract Infections in Children With a Probiotic Containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1, a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03462160
- Acronym / sponsor ID
- UTI probiotic
- Keywords
- Urinary Tract Infection, prophylaxis, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Miralex Sp. z o.o.
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 12 Mar 2018 (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.
The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo.
Detailed description
In previously published European and global guidelines, there has been no consensus among experts regarding the prophylaxis of recurrence urinary tract infections. Depending on the recommendation, the prevention of recurrence UTI should be used, not justified, or should be used in special cases. However, preparations that will be effective in preventing UTI and will not cause bacterial resistance are still sought.
106 patients aged 3 to 18 years with recurrence UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) or children with ≥1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-days prophylaxsis arm (probiotic UroLact containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1) or a 90-days placebo arms.
The primary outcome measure will be frequencies of recurrence of UTI during the 6 months after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo supply for 90 days | Placebo comparator | Other: Placebo control groupPatients will receive placebo (in blinded sachets) |
| Probiotic supply for 90 days | Experimental | Dietary Supplement: Probiotic experimental groupPatients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets). |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls
- ≥1 episode of urinary tract infection in the last 6 months
Key exclusion criteria (5 listed)
- intake of probiotic preparations for ≥1 month in the last 3 months
- known allergy to the study products
- immunosuppression therapy
- disease with immune deficiency
- children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
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 |
|---|---|---|
| Placebo control groupPlacebo will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal. The placebo appearance will be similar to the probiotic. | Other | Placebo supply for 90 days |
| Probiotic experimental groupProbiotic UroLact containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal. | Dietary supplement | Probiotic supply for 90 days |
Primary outcome
frequencies of recurrence of UTI
Time frame: 6 months after intervention
New onset of symptomatic UTI within the 6 months follow-up period.
2 secondary outcomes
frequencies of hospitalization due to UTI
Time frame: 6 months after intervention
the number of days of antibiotic therapy due to UTI
Time frame: 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Results publication: PubMed 26140267Tewary K, Narchi H. Recurrent urinary tract infections in children: Preventive interventions other than prophylactic antibiotics. World J Methodol. 2015 Jun 26;5(2):13-9. doi: 10.5662/wjm.v5.i2.13. eCollection 2015 Jun 26.
- Results publication: PubMed 26695595Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.
- Results publication: PubMed 29102297Hosseini M, Yousefifard M, Ataei N, Oraii A, Mirzay Razaz J, Izadi A. The efficacy of probiotics in prevention of urinary tract infection in children: A systematic review and meta-analysis. J Pediatr Urol. 2017 Dec;13(6):581-591. doi: 10.1016/j.jpurol.2017.08.018. Epub 2017 Oct 9.
- Derived from this study: PubMed 33097017Daniel M, Szymanik-Grzelak H, Turczyn A, Panczyk-Tomaszewska M. Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial. BMC Urol. 2020 Oct 23;20(1):168. doi: 10.1186/s12894-020-00723-1.
- Individual participant dataSharing planned: Undecided
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.
Malgorzata Panczyk-Tomaszewska, Assistant Professor study chair
Medical University of Warsaw
Maria Daniel, MD principal investigator
Medical University of Warsaw
Hanna Szymanik-Grzelak, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic experimental group in people with Prevention of Urinary Tract Infections in Children, run by Medical University of Warsaw at 1 site in Poland.
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 5 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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.
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 Maria Daniel, MD (696477117 ext. 0048, maria.daniel@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequencies of recurrence of UTI (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462160, which also lists 4 linked publications.
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 12 Mar 2018.