Clinical trial NCT05109455: Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant Infection
Lead sponsor: Arafarma Group, S.A.
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change on the incidence of urinary tract infections.
timeFrame: Baseline to 1, 2, 3, 4, 5 and 6 months
Secondary outcomes:
measure: Rate of three types of urinary tract infection: asymptomatic bacteriuria, cystitis, and pyelonephritis between both treatment groups.
timeFrame: Baseline to all study visits up to 6 months.
measure: Rate of urinary tract infections caused by E.coli.
timeFrame: Baseline to all study visits up to 6 months.
measure: Rate of patients who developed bacteremia during the episode of pyelonephritis.
timeFrame: Baseline to all study visits up to 6 months.
measure: Rate of safety episodes between both treatment groups.
timeFrame: From Visit 1, and at each visit, up to 6 months.
measure: Rate of incidence of delayed renal graft function.
timeFrame: From Visit 0 to Visit 1, up to 1 month.
measure: Change from baseline in both treatment groups of concentration of glucose in renal function.
timeFrame: Baseline to all study visits up to 6 months.
measure: Rate of histologically confirmed acute rejection and number of patients who lost the kidney graft.
timeFrame: Baseline to all study visits up to 6 months.
measure: Rate of bacterial colonization of the double J catheter in both treatment groups.
timeFrame: From Visit 0 to Visit 1, up to 1 month.
measure: Type of bacterial colonies of the double J catheter
timeFrame: From Visit 0 to Visit 1, up to 1 month.
measure: Change from baseline in both treatment groups of concentration of Glomerular Filtration Rate (GFR).
timeFrame: Baseline to all study visits up to 6 months.
measure: Change from baseline in both treatment groups of concentration of serum creatinine in renal function.
timeFrame: Baseline to all study visits up to 6 months.
measure: Change from baseline in both treatment groups of concentration of sodium in renal function.
timeFrame: Baseline to all study visits up to 6 months.
measure: Change from baseline in both treatment groups of concentration of potassium in renal function.
timeFrame: Baseline to all study visits up to 6 months.
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Unidad de Trasplante Renal - Hospital Universitari de Bellvitge
name: Edoardo Melilli, Doctor
role: PRINCIPAL_INVESTIGATOR
References: