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

NCT ID: NCT05109455

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2023-02-17

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.

Conditions

Kidney Transplant Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Food supplement

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

Group Type: EXPERIMENTAL

MANOSAR®

Intervention Type: DIETARY_SUPPLEMENT

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

Comparator

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.

Group Type: ACTIVE_COMPARATOR

Proanthocyanidins

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

MANOSAR®

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

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Food Supplement

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arafarma Group, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edoardo Melilli, Doctor

Role: PRINCIPAL_INVESTIGATOR

Unidad de Trasplante Renal - Hospital Universitari de Bellvitge

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

Other Identifiers

ARA-EXP/MN-0801

Identifier Type: -

Identifier Source: org_study_id