Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05109455
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2021-10-21
Brief Title:
Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients
Sponsor:
Arafarma Group SA
Organization:
Arafarma Group SA
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANOTRAS
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 Ecoli 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None