NCT05109455

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

Study of a Food Supplement (Mannose and Proanthocyanidins Prolonged Release 24h) Versus Proanthocyanidins in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Arafarma Group, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-16
• Primary completion: 2021-03-25
• Completion: 2023-02-17
• First posted: 2021-11-05
• Last updated: 2023-03-24

Locations

1 site across 1 country: Spain