Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.

Kidney Transplant Infection Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109455
• Other study ID #: ARA-EXP/MN-0801
• Status: Completed
• Phase: Phase 4
• Start date: April 16, 2019
• Est. completion date: February 17, 2023

Study information

• Verified date: March 2023
• Source: Arafarma Group, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 17, 2023
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Kidney Transplant Infection
• Urinary Tract Infections

Intervention

Dietary Supplement:
• MANOSAR®
MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections.
• Proanthocyanidins
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.

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Arafarma Group, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 1, 2, 3, 4, 5 and 6 months
Secondary	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.	Baseline to all study visits up to 6 months.
Secondary	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.	Baseline to all study visits up to 6 months.
Secondary	Rate of patients who developed bacteremia during the episode of pyelonephritis.	This will be assessed in relation to the performance of urine cultures.	Baseline to all study visits up to 6 months.
Secondary	Rate of safety episodes between both treatment groups.	All episodes will be recorded, whether considered minor or serious, drug-related or not.	From Visit 1, and at each visit, up to 6 months.
Secondary	Rate of incidence of delayed renal graft function.	This is assessed by the need for a hemodialysis session.	From Visit 0 to Visit 1, up to 1 month.
Secondary	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).	Baseline to all study visits up to 6 months.
Secondary	Rate of histologically confirmed acute rejection and number of patients who lost the kidney graft.	Assessed during the 6 months study.	Baseline to all study visits up to 6 months.
Secondary	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.	From Visit 0 to Visit 1, up to 1 month.
Secondary	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.	From Visit 0 to Visit 1, up to 1 month.
Secondary	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).	Baseline to all study visits up to 6 months.
Secondary	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).	Baseline to all study visits up to 6 months.
Secondary	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).	Baseline to all study visits up to 6 months.
Secondary	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).	Baseline to all study visits up to 6 months.