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Controlled Human Urine Transfusion for UTI (SHUTUP)

Primary Purpose

Recurrent Urinary Tract Infection, Safety Issues

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

urine transfusion

About this trial

This is an interventional other trial for Recurrent Urinary Tract Infection focused on measuring Urine transfusion, Recurrent urinary tract infection, Urinary microbiota

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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
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

Sites / Locations

Leiden University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urine transfusion

Arm Description

Intervention: Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days.

Outcomes

Primary Outcome Measures

Safety

The cumulative number of possibly, probably or definitely related adverse events within 6 months of controlled human urine transfusion

Secondary Outcome Measures

Diversity of the urine microbiome after urine transfusion

Change in Shannon diversity index of the bladder microbiome before and after urine transfusion

The composition of the urine microbiome before and after urine transfusion

Percentage of the total microbiome occupied per genus by 16S sequencing

Frequency of UTIs after urine transfusions

The number of UTIs during the follow-up period of 6 months after the urine transfusions

Full Information

NCT ID

NCT03142295

First Posted

May 3, 2017

Last Updated

June 23, 2017

Sponsor

Leiden University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03142295

Brief Title

Controlled Human Urine Transfusion for UTI

Acronym

SHUTUP

Official Title

Safety and Tolerability of Controlled Human Urine Transfusion for Urinary Tract Infection Prevention (SHUTUP): a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 24, 2017 (Anticipated)

Primary Completion Date

January 1, 2018 (Anticipated)

Study Completion Date

February 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Leiden University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Urinary Tract Infection, Safety Issues

Keywords

Urine transfusion, Recurrent urinary tract infection, Urinary microbiota

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective, open label pilot clinical trial.

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Urine transfusion

Arm Type

Experimental

Arm Description

Intervention: Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days.

Intervention Type

Procedure

Intervention Name(s)

urine transfusion

Intervention Description

Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days.

Primary Outcome Measure Information:

Title

Safety

Description

The cumulative number of possibly, probably or definitely related adverse events within 6 months of controlled human urine transfusion

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Diversity of the urine microbiome after urine transfusion

Description

Change in Shannon diversity index of the bladder microbiome before and after urine transfusion

Time Frame

6 months

Title

The composition of the urine microbiome before and after urine transfusion

Description

Percentage of the total microbiome occupied per genus by 16S sequencing

Time Frame

6 months

Title

Frequency of UTIs after urine transfusions

Description

The number of UTIs during the follow-up period of 6 months after the urine transfusions

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Imro Vlasveld, MD

Phone

+31619816389

I.N.Vlasveld@lumc.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Meta Roestenberg, MD

Phone

+31715264400

M.Roestenberg@lumc.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Imro Vlasveld, MD

Organizational Affiliation

LUMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Leiden University Medical Center

City

Leiden

State/Province

Zuid-Holland

ZIP/Postal Code

2333ZA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Imro Vlasveld, MD

Phone

+3171-5262613

I.N.Vlasveld@lumc.nl

First Name & Middle Initial & Last Name & Degree

Meta Roestenberg, MD

Phone

+3171-5262613

M.Roestenberg@lumc.nl

12. IPD Sharing Statement

Plan to Share IPD

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Controlled Human Urine Transfusion for UTI

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