Recurrent Urinary Tract InfectionSHUTUPNCT03142295
Controlled Human Urine Transfusion for UTI
A study testing urine transfusion in people with Recurrent Urinary Tract Infection and Safety Issues, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The primary objective of this pilot study is to investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI's. Seconday and exploratory objectives are to evaluate the diversity of the urine microbiome after urine transfusion, to assess the longevity of changes in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection, Safety Issues
- What is being tested?
- urine transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jun 2017to 1 Feb 2018
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is premenopausal, aged ≥ 18 and ≤45 years
- Subject had recurrent UTI's (≥3 documented UTI's in the last year with documented symptom-free interval of at least 2 weeks) following the definition of a urinary tract infection: the presence of significance bacteruria (10^3 CFU/ml or more), pyuria and fever plus one or more of the following signs and symptoms: suprapubic or flank discomfort, dysuria, bladder spasms or pollakiuria
- Subject has a documented urinary tract infection (see definition), for which oral antibiotic therapy has been initiated.
- Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Subject is able to communicate well with the investigators and is available to attend all study visits.
- Subject has signed informed consent.
- Subject will remain available during the first 3 weeks of the study period (recruiting, intervention and first follow-up).
Who cannot join
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, immune-deficient, psychiatric and other disorders, which could compromise the health of the recipient during the study. These include, but are not limited to, any of the following: positive HIV, HBV or HCV screening tests; the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
- Documented vesico-urethral reflux
- Documented urinary retention > 100 milliliters post-void residual urine
- Anatomic urogenital abnormalities
- Urolithiasis
- Nephrostomy catheters
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- Extra-urogenital infections that require prolonged antibiotic therapy
- Pregnancy
- Use of probiotics and or cranberry juice
- Allergy or intolerance for multiple common prescribed antibiotics
- Carriage of multi drug resistant organisms in faeces and/or urine without regular antibiotic treatment options
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Imro Vlasveld, MD, +3171-5262613, I.N.Vlasveld@lumc.nl
Meta Roestenberg, MD, +3171-5262613, M.Roestenberg@lumc.nl
About this study
Official title: Safety and Tolerability of Controlled Human Urine Transfusion for Urinary Tract Infection Prevention (SHUTUP): a Pilot Study
The primary objective of this pilot study is to investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI's.
Seconday and exploratory objectives are to evaluate the diversity of the urine microbiome after urine transfusion, to assess the longevity of changes in the urine microbiome in patients after urine transfusion over a period of 6 months and to assess the frequency of UTI's after the transfusion.
Read the detailed description
Recurrent urinary tract infections (UTIs) are the most common bacterial infections in nursing homes, in acute care and the general practice. Increasing antibiotic resistance of enterobacteriaciae poses a challenge to the treatment of UTIs. Unlike previously thought, the bladder is colonized with bacteria, which together form the urine microbiome. Recurrent urinary tract infections are associated with a decreased urinary microbiota diversity, potentially making recolonization by bacterial interference in the bladder an alternative therapy for UTI. Pioneering studies showed that local bacterial interference in the bladder can be performed safely and has potential as prophylactic intervention.
We now propose to expand this bacterial interference to a polymicrobial inoculum to increase adherence of the donor microbiome and as such expand the prophylactic effect. This pilot trial will investigate the safety and tolerability of urine transfusion from healthy donors to the bladders of patients with recurrent UTIs.
The primary objective of this pilot study is to investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI's.
Secondary and exploratory objectives are to evaluate the diversity of the urine microbiome after urine transfusion, to assess the longevity of changes in the urine microbiome in patients after urine transfusion over a period of 6 months and to assess the frequency of UTI's after the transfusion.
- Conditions
- Recurrent Urinary Tract Infection, Safety Issues
- Being tested
- urine transfusion
- Keywords
- Urine transfusion, Recurrent urinary tract infection, Urinary microbiota
- 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.
urine transfusionProcedure or surgery
Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Urine transfusion | Experimental | Intervention: Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days. Receives: Procedure: urine transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The cumulative number of possibly, probably or definitely related adverse events within 6 months of controlled human urine transfusion
Measured: 6 months
Secondary outcomes (3)
Diversity of the urine microbiome after urine transfusion
Change in Shannon diversity index of the bladder microbiome before and after urine transfusion
Measured: 6 months
The composition of the urine microbiome before and after urine transfusion
Percentage of the total microbiome occupied per genus by 16S sequencing
Measured: 6 months
Frequency of UTIs after urine transfusions
The number of UTIs during the follow-up period of 6 months after the urine transfusions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start24 Jun 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, open label pilot clinical trial.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ImroVlasveld, Leiden University Medical Center
- Investigators
- Imro Vlasveld, MD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142295
- Sponsor's protocol ID
- NL60330.058.16
- Acronym
- SHUTUP
- Status last verified
- Jun 2017
- First submitted
- 3 May 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Controlled Human Urine Transfusion for Urinary Tract Infection Prevention (SHUTUP): a Pilot Study
- ClinicalTrials.gov ID
- NCT03142295
- Acronym / sponsor ID
- SHUTUP / NL60330.058.16
- Conditions
- Recurrent Urinary Tract Infection, Safety Issues
- Keywords
- Urine transfusion, Recurrent urinary tract infection, Urinary microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 24 Jun 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 5 May 2017 (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 primary objective of this pilot study is to investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI's.
Seconday and exploratory objectives are to evaluate the diversity of the urine microbiome after urine transfusion, to assess the longevity of changes in the urine microbiome in patients after urine transfusion over a period of 6 months and to assess the frequency of UTI's after the transfusion.
Detailed description
Recurrent urinary tract infections (UTIs) are the most common bacterial infections in nursing homes, in acute care and the general practice. Increasing antibiotic resistance of enterobacteriaciae poses a challenge to the treatment of UTIs. Unlike previously thought, the bladder is colonized with bacteria, which together form the urine microbiome. Recurrent urinary tract infections are associated with a decreased urinary microbiota diversity, potentially making recolonization by bacterial interference in the bladder an alternative therapy for UTI. Pioneering studies showed that local bacterial interference in the bladder can be performed safely and has potential as prophylactic intervention.
We now propose to expand this bacterial interference to a polymicrobial inoculum to increase adherence of the donor microbiome and as such expand the prophylactic effect. This pilot trial will investigate the safety and tolerability of urine transfusion from healthy donors to the bladders of patients with recurrent UTIs.
The primary objective of this pilot study is to investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI's.
Secondary and exploratory objectives are to evaluate the diversity of the urine microbiome after urine transfusion, to assess the longevity of changes in the urine microbiome in patients after urine transfusion over a period of 6 months and to assess the frequency of UTI's after the transfusion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, open label pilot clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Urine transfusion | Experimental | Procedure: urine transfusionIntervention: Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is premenopausal, aged ≥ 18 and ≤45 years
- Subject had recurrent UTI's (≥3 documented UTI's in the last year with documented symptom-free interval of at least 2 weeks) following the definition of a urinary tract infection: the presence of significance bacteruria (10^3 CFU/ml or more), pyuria and fever plus one or more of the following signs and symptoms: suprapubic or flank discomfort, dysuria, bladder spasms or pollakiuria
- Subject has a documented urinary tract infection (see definition), for which oral antibiotic therapy has been initiated.
- Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Subject is able to communicate well with the investigators and is available to attend all study visits.
Key exclusion criteria (11 listed)
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, immune-deficient, psychiatric and other disorders, which could compromise the health of the recipient during the study. These include, but are not limited to, any of the following: positive HIV, HBV or HCV screening tests; the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
- Documented vesico-urethral reflux
- Documented urinary retention > 100 milliliters post-void residual urine
- Anatomic urogenital abnormalities
- Urolithiasis
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 |
|---|---|---|
| urine transfusionTwo transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days. | Procedure or surgery | Urine transfusion |
Primary outcome
Safety
Time frame: 6 months
The cumulative number of possibly, probably or definitely related adverse events within 6 months of controlled human urine transfusion
3 secondary outcomes
Diversity of the urine microbiome after urine transfusion
Time frame: 6 months
The composition of the urine microbiome before and after urine transfusion
Time frame: 6 months
Frequency of UTIs after urine transfusions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: No
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Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
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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.
Imro Vlasveld, MD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine transfusion in people with Recurrent Urinary Tract Infection and Safety Issues, run by Leiden University Medical Center at 1 site in Netherlands.
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 7 inclusion and 11 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 26 Jun 2017. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imro Vlasveld, MD (+31619816389, I.N.Vlasveld@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 months). 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 26 Jun 2017.