Recurrent Urinary Tract InfectionsmannoseRUTIsNCT03790254
D Mannose for Prevention and Treatment of RUTIs
An observational study of Recurrent Urinary Tract Infections and Antibiotic Prophylaxis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Recurrent Urinary Tract Infections, Antibiotic Prophylaxis, Antibiotic Resistance
- What is being tested?
- systematic review
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2010to 25 Dec 2018
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Search strategy and selection criteria Only publications with the text and/or the abstract written in the English language were considered. Additional papers cited in the references of the search manuscripts were further examined. Articles not addressing topics of interest were excluded, and the full text of the remaining articles was examined. Our literature search identified 15 articles pertaining to the search terms (Word variations have been searched). Further analysis of these articles resulted in 11 clinical trials which were deemed relevant to our review. The retrieved studies were assessed for their relevance based on the title and abstracts. Finally, studies references were screened in order to identify eventually unknown studies.
Who may be able to join
- recurrent urinary tract infections (RUTIs)
Who cannot join
- Upper urinary tract infections, severe clinical symptoms, fever > 37,5 with lumbar pain
Trial locations and contacts
1 site in 1 country.
Italy1 site
Urology Department Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
About this study
Official title: Oral D Mannose in the Prevention and Treatment of Recurrent Urinary Tract Infections: a Systematic Review
The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.
Read the detailed description
A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English language reports published before December 2018 using the term "recurrent urinary tract infections and d mannose." We searched Medline, Embase, and the Cochrane Register of Controlled Trials since January 2010 to December 2018. Eligible studies did not include non-oral therapy, local (vaginal) treatment in women with RUTIs.
Study eligibility criteria- We identified eligible original articles. The heterogeneity of the available studies, their different rationale and aim, the assumption of d mannose for prophylaxis or treatment of recurrent UTIs need to be taken into account.
- Being tested
- systematic review
- Keywords
- recurrent urinary tract infections, d mannose prophylaxis, antibiotic prophylaxis
- 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.
systematic reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
research literature data on d mannose for prevention and treatment of recurrent urinary tract infections.
literature search of the Medline, Embase, and Cochrane Library databases
Measured: January 2010-December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jan 2010
- Primary completion20 Dec 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Porru, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Daniele Porru, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790254
- Sponsor's protocol ID
- ReviewUTIs
- Acronym
- mannoseRUTIs
- Status last verified
- Dec 2018
- First submitted
- 26 Dec 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral D Mannose in the Prevention and Treatment of Recurrent Urinary Tract Infections: a Systematic Review
- ClinicalTrials.gov ID
- NCT03790254
- Acronym / sponsor ID
- mannoseRUTIs / ReviewUTIs
- Keywords
- recurrent urinary tract infections, d mannose prophylaxis, antibiotic prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 31 Dec 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 aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.
Detailed description
A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English language reports published before December 2018 using the term "recurrent urinary tract infections and d mannose." We searched Medline, Embase, and the Cochrane Register of Controlled Trials since January 2010 to December 2018. Eligible studies did not include non-oral therapy, local (vaginal) treatment in women with RUTIs.
Study eligibility criteria- We identified eligible original articles. The heterogeneity of the available studies, their different rationale and aim, the assumption of d mannose for prophylaxis or treatment of recurrent UTIs need to be taken into account.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Search strategy and selection criteria Only publications with the text and/or the abstract written in the English language were considered. Additional papers cited in the references of the search manuscripts were further examined. Articles not addressing topics of interest were excluded, and the full text of the remaining articles was examined. Our literature search identified 15 articles pertaining to the search terms (Word variations have been searched). Further analysis of these articles resulted in 11 clinical trials which were deemed relevant to our review. The retrieved studies were assessed for their relevance based on the title and abstracts. Finally, studies references were screened in order to identify eventually unknown studies.
Key inclusion criteria (1 listed)
- recurrent urinary tract infections (RUTIs)
Key exclusion criteria (1 listed)
- Upper urinary tract infections, severe clinical symptoms, fever > 37,5 with lumbar pain
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 |
|---|---|---|
| systematic review | Other | – |
Primary outcome
research literature data on d mannose for prevention and treatment of recurrent urinary tract infections.
Time frame: January 2010-December 2018
literature search of the Medline, Embase, and Cochrane Library databases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Daniele Porru, MD principal investigator
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Urinary Tract Infections and Antibiotic Prophylaxis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Dec 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 Italy. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
research literature data on d mannose for prevention and treatment of recurrent urinary tract infections. (time frame: January 2010-December 2018). 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 31 Dec 2018.