An interventional study of OMNi-BiOTiC® 41167 and Placebo in Urinary Tract Infections, Kidney Transplant Rejection and Kidney Transplant Infection, sponsored by University Hospital, Udine, Italy. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by University Hospital, Udine, Italy · Not applicable, Interventional, and Prevention
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:
Participants will:
Background
Urinary tract infections (UTI) and graft rejection in kidney transplanted (KT) patients are currently the most frequent complications in the short-term, with a reported incidence of 17-51% and 6- 11% within the first year, respectively. The pathogenesis of such complications is tightly related and is determined by multifactorial mechanisms. Recent studies have shown that gut microbiota may have a crucial role in the pathogenesis of both post-KT UTI and graft rejection. Following transplantation, KT recipients show measurable alterations in microbial diversity, composition and function, and such gut dysbiosis may not only favor the proliferation of pathogens but also modify the immuno-inflammatory profile of recipients, inducing a pro- inflammatory state. Moreover, gut microbiota does metabolize immunosuppressant drugs, variably modifying their pharmacokinetic characteristics. A significant correlation between gut microbiota species and urine microbial isolates in a context of UTI have been consistently identified, and certain microbiota profiles have been alternatively associated with graft immune tolerance and graft rejection episodes. According to the International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statements, probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.
Recent studies have shown that probiotic supplementation in KT recipients may variably improve kidney function in patients with chronic kidney disease as well as induce graft tolerance and decrease the risk of recurrent Clostridioides difficile infection. However, the evidence of possible beneficial effects of probiotics, including on UTI incidence in KT patients is missing.
Protocol
All Adult, Caucasian patients treated with kidney transplantation (KT) at SOC Clinica Chirurgica, ASUFC, Udine, Italy, from September 2024, and with an uneventful course during the first postoperative month (POM) will be evaluated for enrollment. Written informed consent to take part in the study will be obtained from each participant after being informed on study design, aims and potential adverse events.
The 132 subjects will be randomly allocated to either the probiotic arm or the placebo arm (control group). Group allocation will be double-blind. A computer random number algorithm (1:1 allocation ratio) will randomize participants, using blocks of four.
In the intervention group, patients will receive two sachets daily of OMNi-BiOTiC® 41167 for 6 months, while the control group will receive an equal amount of similar looking and tasting placebo.
Both study groups will remain on their standard diet and drug regimen during the study period. Adherence to therapy will be measured by sachet count.
The post-transplant clinical surveillance will follow the routine follow-up schedule for KT patients at the Department of Nephrology, ASUFC, Udine, Italy.
At enrollment (POM 1, visit 1) patients will be assessed with routine physical examination, clinical interview, blood exams, tacrolimus dosage and plasma concentration, Torque Teno Virus (TTV) and Acellular Growth Retardation Assay (AGRA) tests, urine tests, urine culture; Nova Food Frequency Questionnaires (NFFQ), Acute Cystitis Symptom Score (ACSS), Gastrointestinal Symptom Rating Scale, Irritable Bowel Syndrome version (GSRS-IBS, AstraZeneca R\&D, SE-431 83 Mölndal, Sweden.) and quality of life SF-12 (Hogrefe Verlag, Göttingen, Germany) questionnaires will be administered; clinical data and laboratory data will be collected and saved in dedicated database; urine and stool samples will be collected and stored for microbiota determination; study product will be provided.
BK virus surveillance according to the routine follow-up schedule will be based on viral load measurement in blood and urine samples at POM 1, 3 and 6.
During the treatment period (POM1-POM7, visits 2-15) patients will be assessed with physical examination, routine blood exams, tacrolimus dosage and plasma concentration, urine tests, urine culture; ACSS, GSRS-IBS and SF-12 questionnaires will be administered; clinical data and laboratory data will be collected and saved in dedicated database. Study products will be provided regularly every fourth week.
At the end of the treatment (POM7, visit 16) patients will be assessed with physical examination, routine blood exams, tacrolimus dosage and plasma concentration, TTV and AGRA tests, urine tests, urine culture; NFFQ, ACSS, GSRS-IBS and SF-12 questionnaires will be administered; clinical data and laboratory data will be collected and saved in dedicated database; urine and stool samples will be collected and stored for microbiota determination.
Adverse events and serious adverse events will be evaluated at every visit.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 132 is close to the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University Hospital, Udine, Italy is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Dietary Supplement: OMNi-BiOTiC® 41167
Dietary Supplement: Placebo
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.
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.
Urinary tract infection rates
UTI will be diagnosed based on seriated urine microbiological cultures. Type of bacteria isolated, bacterial load and antibiogram will be also recorded and confronted
Time frame: from postoperative month 1 to postoperative month 7
Rates of Urinary tract symptoms
Urinary tract symptoms will be assessed and diagnosed with seriated ACSS (Acute Cystitis Symptom Score, 0-39; the higher the score, the worse the severity) questionnaires
Time frame: from postoperative month 1 to postoperative month 7
Rate of biopsy proven acute rejection
Acute rejection diagnosis will be based on histopathological examination of graft specimen from percutaneous graft biopsy
Time frame: from postoperative month 1 to postoperative month 7
Immunosuppression therapy
Immunosuppression therapy will be evaluated with seriated measurements of tacrolimus dosage-to-plasma concentration (TAC-D/C) ratios
Time frame: from postoperative month 1 to postoperative month 7
Immunosuppression strength
Immunosuppression strength will be evaluated with seriated plasma AGRA and TTV levels.
Time frame: from postoperative month 1 to postoperative month 7
Kidney graft function
Kidney graft function will be assessed with creatinine serum levels
Time frame: from postoperative month 1 to postoperative month 7
Gut microbiome
Gut microbiome will be determined by 16S analysis: variation of alpha and beta diversity will be assessed
Time frame: at postoperative month 1 and postoperative month 7
Bladder microbiome
Bladder microbiome will be determined by 16S analysis: variation of alpha and beta diversity will be assessed
Time frame: at postoperative month 1 and postoperative month 7
Quality of life according to SF-12 questionnaire
Quality of life will be evaluated with seriated SF-12 (Short form health survey) questionnaires;
Time frame: from postoperative month 1 to postoperative month 7
Gastrointestinal symptoms according to GSRS-IBS questionnaire
GI symptoms will be evaluated with seriated GSRS-IBS (The Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome) questionnaires
Time frame: from postoperative month 1 to postoperative month 7
Adverse events
Incidence of related and unrelated adverse event will be evaluated as a composite outcome based on evidence of abnormal physical examination findings, abnormal laboratory tests results, abnormal imaging examination and/or abnormal microbiological analysis
Time frame: from postoperative month 1 to postoperative month 7
Plan to share: No
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University Hospital, Udine, Italy