Back to resultsEffects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients. (MANOTRAS)
Primary Purpose
Kidney Transplant Infection
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
MANOSAR®
Proanthocyanidins
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplant Infection
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years.
- Recipients of a cadaveric donor kidney transplant.
- Patients who are trained to give their informed consent.
Exclusion Criteria:
- Recipients of a kidney transplant who do not authorize their participation in the study by informed consent.
- Recipients of a transplant of an organ other than the kidney.
- Patients with Bricker or Studer neobladders.
- Patients in need of intermittent self-catheterization prior to kidney transplantation.
- Any medical, psychiatric or family condition that, in the opinion of the investigator, may endanger or compromise the patient's ability to participate in the study.
- Pregnant or lactating patients.
- Having participated in clinical trials in the previous 3 months or participating in another clinical study promoted by the pharmaceutical industry, in which the promoter already establishes the treatment for UTI.
Sites / Locations
- Hospital Universitari de Bellvitge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Food supplement
Comparator
Arm Description
MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections.
The comparator are Proanthocyanidins of continuous-release, which are isolated from cranberry, and prevents the adhesion of uropathogenic bacteria such a E.coli to the wall of the urothelium.
Outcomes
Primary Outcome Measures
Change on the incidence of urinary tract infections.
To assess the magnitude of the change from baseline incidence of urinary tract infections in kidney transplant patients at one month, two months and three months of treatment and at four, five and six months of follow-up.
Secondary Outcome Measures
Rate of three types of urinary tract infection: asymptomatic bacteriuria, cystitis, and pyelonephritis between both treatment groups.
All information regarding these infections will be recorded.
Rate of urinary tract infections caused by E.coli.
E. coli will be assessed by urine cultures, which are performed according to the usual clinical practice of the site (weekly - from Visit 0 to Visit 1 (4 urine cultures); fortnightly - from Visit 1 to Visit 3 (4 urine cultures); monthly - from Visit 3 to Visit 6 (3 urine cultures)). Also if there is suspected infection based on clinical criteria there will be performed also an urine culture.
Rate of patients who developed bacteremia during the episode of pyelonephritis.
This will be assessed in relation to the performance of urine cultures.
Rate of safety episodes between both treatment groups.
All episodes will be recorded, whether considered minor or serious, drug-related or not.
Rate of incidence of delayed renal graft function.
This is assessed by the need for a hemodialysis session.
Change from baseline in both treatment groups of concentration of glucose in renal function.
The concentration of glucose (mmol/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Rate of histologically confirmed acute rejection and number of patients who lost the kidney graft.
Assessed during the 6 months study.
Rate of bacterial colonization of the double J catheter in both treatment groups.
This is assessed by the microbiological analysis of the tips of the double J catheter will be performed between Visit 0 and Visit 1, once it has been removed 21-27 days after kidney transplantation.
Type of bacterial colonies of the double J catheter
This is assessed by the microbiological analysis of the tips of the double J catheter will be performed between Visit 0 and Visit 1, once it has been removed 21-27 days after kidney transplantation.
Change from baseline in both treatment groups of concentration of Glomerular Filtration Rate (GFR).
The calculation of GFR (ml/min) is estimated with a blood test, which is completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Change from baseline in both treatment groups of concentration of serum creatinine in renal function.
The concentration of serum creatinine (µmol/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Change from baseline in both treatment groups of concentration of sodium in renal function.
The concentration of sodium (mEq/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Change from baseline in both treatment groups of concentration of potassium in renal function.
The concentration of potassium (mEq/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05109455
Brief Title
Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
Acronym
MANOTRAS
Official Title
Study of a Food Supplement (Mannose and Proanthocyanidins Prolonged Release 24h) Versus Proanthocyanidins in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
February 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arafarma Group, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The incidence of Urinary tract infections (UTIs) is very high in kidney transplant patients. Most UTIs occur during the first six months (82% within the first three months) of kidney transplantation and are frequently recurrent. The component D-mannose of our authorized food supplement acts by inhibiting the adherence of E.coli to the urothelium. It also has a controlled release formula that ensures the presence in urine of D-mannose and the other components during 24 hours. This is the reason why this experimental study aims to demonstrate that the oral intake of this food supplement is effective in the prevention of UTIs in kidney transplant patients.
Detailed Description
The study tries to analyze the impact of a food supplement (Manosar®) on the incidence of urinary infections in patients undergoing kidney transplantation.
The patients will be randomly distributed (1: 1 ratio) into two treatment groups of 30 patients each. In one group, they will be treated with Manosar®, and in the other group they will be treated with Proanthocyanidins. All patients will be followed for 6 months, being the first three months of the study drug administration.
This experimental study is double-blinded and there are 7 monthly study visits. Properties of D-mannose and Proanthocyanidins make interesting to evaluate the clinical benefit of the use of food supplements with D-mannose and Proanthocyanidins in order to prevent the UTIs without antibiotics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food supplement
Arm Type
Experimental
Arm Description
MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections.
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
The comparator are Proanthocyanidins of continuous-release, which are isolated from cranberry, and prevents the adhesion of uropathogenic bacteria such a E.coli to the wall of the urothelium.
Intervention Type
Dietary Supplement
Intervention Name(s)
MANOSAR®
Other Intervention Name(s)
Food Supplement
Intervention Description
MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections.
Intervention Type
Dietary Supplement
Intervention Name(s)
Proanthocyanidins
Intervention Description
The comparator are Proanthocyanidins of continuous-release, which are isolated from cranberry, and prevents the adhesion of uropathogenic bacteria such a E.coli to the wall of the urothelium.
Primary Outcome Measure Information:
Title
Change on the incidence of urinary tract infections.
Description
To assess the magnitude of the change from baseline incidence of urinary tract infections in kidney transplant patients at one month, two months and three months of treatment and at four, five and six months of follow-up.
Time Frame
Baseline to 1, 2, 3, 4, 5 and 6 months
Secondary Outcome Measure Information:
Title
Rate of three types of urinary tract infection: asymptomatic bacteriuria, cystitis, and pyelonephritis between both treatment groups.
Description
All information regarding these infections will be recorded.
Time Frame
Baseline to all study visits up to 6 months.
Title
Rate of urinary tract infections caused by E.coli.
Description
E. coli will be assessed by urine cultures, which are performed according to the usual clinical practice of the site (weekly - from Visit 0 to Visit 1 (4 urine cultures); fortnightly - from Visit 1 to Visit 3 (4 urine cultures); monthly - from Visit 3 to Visit 6 (3 urine cultures)). Also if there is suspected infection based on clinical criteria there will be performed also an urine culture.
Time Frame
Baseline to all study visits up to 6 months.
Title
Rate of patients who developed bacteremia during the episode of pyelonephritis.
Description
This will be assessed in relation to the performance of urine cultures.
Time Frame
Baseline to all study visits up to 6 months.
Title
Rate of safety episodes between both treatment groups.
Description
All episodes will be recorded, whether considered minor or serious, drug-related or not.
Time Frame
From Visit 1, and at each visit, up to 6 months.
Title
Rate of incidence of delayed renal graft function.
Description
This is assessed by the need for a hemodialysis session.
Time Frame
From Visit 0 to Visit 1, up to 1 month.
Title
Change from baseline in both treatment groups of concentration of glucose in renal function.
Description
The concentration of glucose (mmol/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time Frame
Baseline to all study visits up to 6 months.
Title
Rate of histologically confirmed acute rejection and number of patients who lost the kidney graft.
Description
Assessed during the 6 months study.
Time Frame
Baseline to all study visits up to 6 months.
Title
Rate of bacterial colonization of the double J catheter in both treatment groups.
Description
This is assessed by the microbiological analysis of the tips of the double J catheter will be performed between Visit 0 and Visit 1, once it has been removed 21-27 days after kidney transplantation.
Time Frame
From Visit 0 to Visit 1, up to 1 month.
Title
Type of bacterial colonies of the double J catheter
Description
This is assessed by the microbiological analysis of the tips of the double J catheter will be performed between Visit 0 and Visit 1, once it has been removed 21-27 days after kidney transplantation.
Time Frame
From Visit 0 to Visit 1, up to 1 month.
Title
Change from baseline in both treatment groups of concentration of Glomerular Filtration Rate (GFR).
Description
The calculation of GFR (ml/min) is estimated with a blood test, which is completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time Frame
Baseline to all study visits up to 6 months.
Title
Change from baseline in both treatment groups of concentration of serum creatinine in renal function.
Description
The concentration of serum creatinine (µmol/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time Frame
Baseline to all study visits up to 6 months.
Title
Change from baseline in both treatment groups of concentration of sodium in renal function.
Description
The concentration of sodium (mEq/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time Frame
Baseline to all study visits up to 6 months.
Title
Change from baseline in both treatment groups of concentration of potassium in renal function.
Description
The concentration of potassium (mEq/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time Frame
Baseline to all study visits up to 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years.
Recipients of a cadaveric donor kidney transplant.
Patients who are trained to give their informed consent.
Exclusion Criteria:
Recipients of a kidney transplant who do not authorize their participation in the study by informed consent.
Recipients of a transplant of an organ other than the kidney.
Patients with Bricker or Studer neobladders.
Patients in need of intermittent self-catheterization prior to kidney transplantation.
Any medical, psychiatric or family condition that, in the opinion of the investigator, may endanger or compromise the patient's ability to participate in the study.
Pregnant or lactating patients.
Having participated in clinical trials in the previous 3 months or participating in another clinical study promoted by the pharmaceutical industry, in which the promoter already establishes the treatment for UTI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edoardo Melilli, Doctor
Organizational Affiliation
Unidad de Trasplante Renal - Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
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