PRObiotics for KIdney Transplantation

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

Conditions

• Urinary Tract Infections
• Kidney Transplant Rejection
• Kidney Transplant Infection
• Dysbiosis

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Winclove Probiotics B.V.

  collaborator INDUSTRY

• Institut AllergoSan

  collaborator UNKNOWN

• University Hospital, Udine, Italy

  lead OTHER

Principal Investigators

• Umberto Baccarani, MD PhD · Department of Medicine, University of Udine

• Riccardo Pravisani, MD PhD · Department of Medicine, University of Udine

• Patrizia Tulissi, MD · Azienda Sanitaria Universitaria Friuli Centrale

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-15

Primary Completion

2027-10-15

Completion

2028-04-15

Countries

• Italy

Study Locations