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

NCT05109455 | Completed Phase 4

• 1 other identifier: ARA-EXP/MN-0801
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Rate of three types of urinary tract infection: asymptomatic bacteriuria, cystitis, and pyelonephritis between both treatment groups.

  Baseline to all study visits up to 6 months.

• Rate of urinary tract infections caused by E.coli.

  Baseline to all study visits up to 6 months.

• Rate of patients who developed bacteremia during the episode of pyelonephritis.

  Baseline to all study visits up to 6 months.

• Rate of safety episodes between both treatment groups.

  From Visit 1, and at each visit, up to 6 months.

• Rate of incidence of delayed renal graft function.

  From Visit 0 to Visit 1, up to 1 month.

Study Arms (2)

Food supplement

EXPERIMENTAL

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: MANOSAR®

Comparator

ACTIVE 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.

Dietary Supplement: Proanthocyanidins

Interventions

MANOSAR® 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.

Also known as: Food Supplement

Food supplement

Proanthocyanidins 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.

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years.
• Recipients of a cadaveric donor kidney transplant.
• Patients who are trained to give their informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arafarma Group, S.A.: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

MeSH Terms

Interventions

Dietary Supplements; Proanthocyanidins

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tannins; Biopolymers; Polymers; Macromolecular Substances

Study Officials

• Edoardo Melilli, Doctor

  Unidad de Trasplante Renal - Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 5, 2021
• Study Start: April 16, 2019
• Primary Completion: March 25, 2021
• Study Completion: February 17, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

ES (1)