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

NCT05109455 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

  • Kidney Transplant Infection

Interventions

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.

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.

Sponsors & Collaborators

  • Arafarma Group, S.A.

    lead INDUSTRY

Principal Investigators

  • Edoardo Melilli, Doctor · Unidad de Trasplante Renal - Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2021-03-25
Completion
2023-02-17

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05109455 on ClinicalTrials.gov