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PRObiotics for KIdney Transplantation
Sponsor: University Hospital, Udine, Italy
Summary
The goal of this clinical trial is to assess if dietary supplememtation with OMNi-BiOTiC® 41167 reduces the risk of urinary tract infections in kidney transplant recipients. It will also assess whether it reduces the risk of graft rejection, modify immunosuppressive regimen, improves post-transplant gastrointestinal and bladder microbiome, gastrointestinal symptoms and quality of life. The main questions it aims to answer are: * Does daily intake of OMNi-BiOTiC® 41167 reduce the incidence and number of episodes of urinary tract infections? * Does daily intake of OMNi-BiOTiC® 41167 reduce the incidence and number of episodes of acute graft rejection? * Does dietary supplementation with OMNi-BiOTiC® 41167 modify gut and bladder microbiome? * Does dietary supplementation with OMNi-BiOTiC® 41167 modify tacrolimus metabolism and immunosuppressive state? * Does dietary supplementation with OMNi-BiOTiC® 41167 improves gastrointestinal symptoms and quality of life? Researchers will compare drug OMNi-BiOTiC® 41167 to a placebo (a look-alike substance that contains no drug) to see if OMNi-BiOTiC® 41167 exerts any clinically relevant beneficial effect. Participants will: * Take OMNi-BiOTiC® 41167 or a placebo every day for 6 months * Undergo clinical surveillance with seriated visit the clinics for checkups and laboratory analysis * Provide seriated urine and stool samples for microbiome analysis * Respond to seriated questionnaire on gastrointestinal symptoms and quality of life
Official title: Impact of Probiotic Supplementation on Urinary Tract Infections and Clinically Relevant Outcomes of Kidney Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2024-11-15
Completion Date
2028-04-15
Last Updated
2025-02-13
Healthy Volunteers
No
Interventions
OMNi-BiOTiC® 41167
The probiotic OMNi-BiOTiC® 41167 consists of 3g of 3 x 10\^9 CFU total L. gasseri W15, L. plantarum W1, L. plantarum W21, B. lactis W51, L. acidophilus W70 and L. reuteri W192 per sachet of which two are to be taken each day. Additional non-probiotic components are cranberry-extract (0.01g), D-mannose (0,4 g), vitamin D (2,25µg), maize starch and hydrolyzed rice protein. All the strains in OMNi-BiOTiC® 41167 are specifically tested and selected for their inhibition potential against the known most common uropathogens like the uropathogenic Escherichia coli (UPEC), Klebsiella pneumonia, Proteus mirabilis and Entercoccus faecalis.
Placebo
The placebo consists of all components of OMNi-BiOTiC® 41167, except the probiotic bacteria, cranberry-extract, D-mannose and vitamin D. It has the same smell, taste and texture as the OMNi-BiOTiC® 41167.
Locations (1)
Presidio Ospedaliero Universitario S. Maria della Misericordia, ASUFC
Udine, Italy