Urinary Tract InfectionsProKiTNCT06825117
PRObiotics for KIdney Transplantation
A study testing OMNi-BiOTiC® 41167 in people with Urinary Tract Infections and Kidney Transplant Rejection, run by University Hospital, Udine, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Tract Infections, Kidney Transplant Rejection, Kidney Transplant Infection
- What is being tested?
- OMNi-BiOTiC® 41167
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2024to 15 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willingness and capability to provide written informed consent/assent for the trial;
- ≥18 and <75 years of age on day of signing informed consent;
- patients at 30 days post kidney transplantation with surgically uneventful course during the first postoperative month
Who cannot join
- pediatric patients (<18 years)
- elderly patients (>75 years)
- combined transplantation recipients
- patients with pre-transplant inflammatory bowel disease or irritable bowel syndrome (according to Roma criteria), previous bowel resection or stoma;
- pre-/probiotic supplementation within 1 month of study commencement or use of other probiotics-containing products during the intervention period;
- any proven gastrointestinal infection or disorder during the first post-transplant month or at the time of study enrollment;
Show all 9Show fewer
- any surgical complication during the first post-transplant month or at the time of study enrollment;
- evidence of ongoing acute rejection, urinary tract infection or other medical complications at the time of enrollment
- known intolerance or allergy to any of the ingredients in both OMNi-BiOTiC® 41167 and placebo
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Presidio Ospedaliero Universitario S. Maria della Misericordia, ASUFC
Udine, 33100
About this study
Official title: Impact of Probiotic Supplementation on Urinary Tract Infections and Clinically Relevant Outcomes of Kidney Transplant Recipients
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:
Read more
- 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
Read the detailed description
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\&amp;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.
- Conditions
- Urinary Tract Infections, Kidney Transplant Rejection, Kidney Transplant Infection, Dysbiosis
- Being tested
- OMNi-BiOTiC® 41167, Placebo
- Medical subject headings
- Urinary Tract Infections, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNi-BiOTiC® 41167Dietary supplement
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.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Not described Receives: Dietary Supplement: OMNi-BiOTiC® 41167 |
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: from postoperative month 1 to postoperative month 7
Secondary outcomes (6)
Rate of biopsy proven acute rejection
Acute rejection diagnosis will be based on histopathological examination of graft specimen from percutaneous graft biopsy
Measured: 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
Measured: from postoperative month 1 to postoperative month 7
Immunosuppression strength
Immunosuppression strength will be evaluated with seriated plasma AGRA and TTV levels.
Measured: from postoperative month 1 to postoperative month 7
Kidney graft function
Kidney graft function will be assessed with creatinine serum levels
Measured: 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
Measured: 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
Measured: at postoperative month 1 and postoperative month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start15 Nov 2024
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Udine, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Winclove Probiotics B.V., Institut AllergoSan Pharma GmbH
- Responsible party
- Principal investigator, Umberto Baccarani, University Hospital, Udine, Italy
- Investigators
- Umberto Baccarani, MD PhD, Principal investigator, Department of Medicine, University of UdineRiccardo Pravisani, MD PhD, Principal investigator, Department of Medicine, University of UdinePatrizia Tulissi, MD, Study director, Azienda Sanitaria Universitaria Friuli Centrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825117
- Sponsor's protocol ID
- 64/2024
- Acronym
- ProKiT
- Status last verified
- Feb 2025
- First submitted
- 10 Oct 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winichakoon P, Chaiwarith R, Chattipakorn N, Chattipakorn SC. Impact of gut microbiota on kidney transplantation. Transplant Rev (Orlando). 2022 Jan;36(1):100668. doi: 10.1016/j.trre.2021.100668. Epub 2021 Oct 18.
PubMed 34688985Liu S, Liu H, Chen L, Liang SS, Shi K, Meng W, Xue J, He Q, Jiang H. Effect of probiotics on the intestinal microbiota of hemodialysis patients: a randomized trial. Eur J Nutr. 2020 Dec;59(8):3755-3766. doi: 10.1007/s00394-020-02207-2. Epub 2020 Feb 28.
PubMed 32112136Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
PubMed 28611480Zaza G, Dalla Gassa A, Felis G, Granata S, Torriani S, Lupo A. Impact of maintenance immunosuppressive therapy on the fecal microbiome of renal transplant recipients: Comparison between an everolimus- and a standard tacrolimus-based regimen. PLoS One. 2017 May 24;12(5):e0178228. doi: 10.1371/journal.pone.0178228. eCollection 2017.
PubMed 28542523Coussement J, Maggiore U, Manuel O, Scemla A, Lopez-Medrano F, Nagler EV, Aguado JM, Abramowicz D; European Renal Association-European Dialysis Transplant Association (ERA-EDTA) Developing Education Science and Care for Renal Transplantation in European States (DESCARTES) working group and the European Study Group for Infections in Compromised Hosts (E; COLLABORATORS (IN ALPHABETICAL ORDER); European Renal Association-European Dialysis Transplant Association (ERA-EDTA) Developing Education Science and Care for Renal Transplantation in European States (DESCARTES) working group and the European Study Group for Infections in Compromised Hosts (ESGICH) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Diagnosis and management of asymptomatic bacteriuria in kidney transplant recipients: a survey of current practice in Europe. Nephrol Dial Transplant. 2018 Sep 1;33(9):1661-1668. doi: 10.1093/ndt/gfy078.
PubMed 29635410Eikmans M, Gielis EM, Ledeganck KJ, Yang J, Abramowicz D, Claas FFJ. Non-invasive Biomarkers of Acute Rejection in Kidney Transplantation: Novel Targets and Strategies. Front Med (Lausanne). 2019 Jan 8;5:358. doi: 10.3389/fmed.2018.00358. eCollection 2018.
PubMed 30671435Garcia-Martinez Y, Borriello M, Capolongo G, Ingrosso D, Perna AF. The Gut Microbiota in Kidney Transplantation: A Target for Personalized Therapy? Biology (Basel). 2023 Jan 20;12(2):163. doi: 10.3390/biology12020163.
PubMed 36829442Przybycinski J, Drozdzal S, Wilk A, Dziedziejko V, Szumilas K, Pawlik A. The Effect of the Gut Microbiota on Transplanted Kidney Function. Int J Mol Sci. 2023 Jan 9;24(2):1260. doi: 10.3390/ijms24021260.
PubMed 36674775Strohaeker J, Aschke V, Koenigsrainer A, Nadalin S, Bachmann R. Urinary Tract Infections in Kidney Transplant Recipients-Is There a Need for Antibiotic Stewardship? J Clin Med. 2021 Dec 31;11(1):226. doi: 10.3390/jcm11010226.
PubMed 35011966Tamargo CL, Kant S. Pathophysiology of Rejection in Kidney Transplantation. J Clin Med. 2023 Jun 19;12(12):4130. doi: 10.3390/jcm12124130.
PubMed 37373823Ye J, Yao J, He F, Sun J, Zhao Z, Wang Y. Regulation of gut microbiota: a novel pretreatment for complications in patients who have undergone kidney transplantation. Front Cell Infect Microbiol. 2023 Jun 6;13:1169500. doi: 10.3389/fcimb.2023.1169500. eCollection 2023.
PubMed 37346031
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotic Supplementation on Urinary Tract Infections and Clinically Relevant Outcomes of Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06825117
- Acronym / sponsor ID
- ProKiT / 64/2024
- Conditions
- Urinary Tract Infections, Kidney Transplant Rejection, Kidney Transplant Infection, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University Hospital, Udine, ItalyUniversity, hospital or other
- Collaborators
- Winclove Probiotics B.V., Institut AllergoSan Pharma GmbH
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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\&amp;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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: OMNi-BiOTiC® 41167 |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- willingness and capability to provide written informed consent/assent for the trial;
- ≥18 and <75 years of age on day of signing informed consent;
- patients at 30 days post kidney transplantation with surgically uneventful course during the first postoperative month
Key exclusion criteria (9 listed)
- pediatric patients (<18 years)
- elderly patients (>75 years)
- combined transplantation recipients
- patients with pre-transplant inflammatory bowel disease or irritable bowel syndrome (according to Roma criteria), previous bowel resection or stoma;
- pre-/probiotic supplementation within 1 month of study commencement or use of other probiotics-containing products during the intervention period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNi-BiOTiC® 41167The 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 | Probiotic group |
| PlaceboThe 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. | Dietary supplement | Placebo group |
Primary outcome
Urinary tract infection rates
Time frame: from postoperative month 1 to postoperative month 7
UTI will be diagnosed based on seriated urine microbiological cultures. Type of bacteria isolated, bacterial load and antibiogram will be also recorded and confronted
Rates of Urinary tract symptoms
Time frame: from postoperative month 1 to postoperative month 7
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
6 secondary outcomes
Rate of biopsy proven acute rejection
Time frame: from postoperative month 1 to postoperative month 7
Immunosuppression therapy
Time frame: from postoperative month 1 to postoperative month 7
Immunosuppression strength
Time frame: from postoperative month 1 to postoperative month 7
Kidney graft function
Time frame: from postoperative month 1 to postoperative month 7
Gut microbiome
Time frame: at postoperative month 1 and postoperative month 7
Bladder microbiome
Time frame: at postoperative month 1 and postoperative month 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 34688985Winichakoon P, Chaiwarith R, Chattipakorn N, Chattipakorn SC. Impact of gut microbiota on kidney transplantation. Transplant Rev (Orlando). 2022 Jan;36(1):100668. doi: 10.1016/j.trre.2021.100668. Epub 2021 Oct 18.
- Background: PubMed 32112136Liu S, Liu H, Chen L, Liang SS, Shi K, Meng W, Xue J, He Q, Jiang H. Effect of probiotics on the intestinal microbiota of hemodialysis patients: a randomized trial. Eur J Nutr. 2020 Dec;59(8):3755-3766. doi: 10.1007/s00394-020-02207-2. Epub 2020 Feb 28.
- Background: PubMed 28611480Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
- Background: PubMed 28542523Zaza G, Dalla Gassa A, Felis G, Granata S, Torriani S, Lupo A. Impact of maintenance immunosuppressive therapy on the fecal microbiome of renal transplant recipients: Comparison between an everolimus- and a standard tacrolimus-based regimen. PLoS One. 2017 May 24;12(5):e0178228. doi: 10.1371/journal.pone.0178228. eCollection 2017.
- Background: PubMed 29635410Coussement J, Maggiore U, Manuel O, Scemla A, Lopez-Medrano F, Nagler EV, Aguado JM, Abramowicz D; European Renal Association-European Dialysis Transplant Association (ERA-EDTA) Developing Education Science and Care for Renal Transplantation in European States (DESCARTES) working group and the European Study Group for Infections in Compromised Hosts (E; COLLABORATORS (IN ALPHABETICAL ORDER); European Renal Association-European Dialysis Transplant Association (ERA-EDTA) Developing Education Science and Care for Renal Transplantation in European States (DESCARTES) working group and the European Study Group for Infections in Compromised Hosts (ESGICH) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Diagnosis and management of asymptomatic bacteriuria in kidney transplant recipients: a survey of current practice in Europe. Nephrol Dial Transplant. 2018 Sep 1;33(9):1661-1668. doi: 10.1093/ndt/gfy078.
- Background: PubMed 30671435Eikmans M, Gielis EM, Ledeganck KJ, Yang J, Abramowicz D, Claas FFJ. Non-invasive Biomarkers of Acute Rejection in Kidney Transplantation: Novel Targets and Strategies. Front Med (Lausanne). 2019 Jan 8;5:358. doi: 10.3389/fmed.2018.00358. eCollection 2018.
- Background: PubMed 36829442Garcia-Martinez Y, Borriello M, Capolongo G, Ingrosso D, Perna AF. The Gut Microbiota in Kidney Transplantation: A Target for Personalized Therapy? Biology (Basel). 2023 Jan 20;12(2):163. doi: 10.3390/biology12020163.
- Background: PubMed 36674775Przybycinski J, Drozdzal S, Wilk A, Dziedziejko V, Szumilas K, Pawlik A. The Effect of the Gut Microbiota on Transplanted Kidney Function. Int J Mol Sci. 2023 Jan 9;24(2):1260. doi: 10.3390/ijms24021260.
- Background: PubMed 35011966Strohaeker J, Aschke V, Koenigsrainer A, Nadalin S, Bachmann R. Urinary Tract Infections in Kidney Transplant Recipients-Is There a Need for Antibiotic Stewardship? J Clin Med. 2021 Dec 31;11(1):226. doi: 10.3390/jcm11010226.
- Background: PubMed 37373823Tamargo CL, Kant S. Pathophysiology of Rejection in Kidney Transplantation. J Clin Med. 2023 Jun 19;12(12):4130. doi: 10.3390/jcm12124130.
- Background: PubMed 37346031Ye J, Yao J, He F, Sun J, Zhao Z, Wang Y. Regulation of gut microbiota: a novel pretreatment for complications in patients who have undergone kidney transplantation. Front Cell Infect Microbiol. 2023 Jun 6;13:1169500. doi: 10.3389/fcimb.2023.1169500. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Umberto Baccarani, MD PhD principal investigator
Department of Medicine, University of Udine
Riccardo Pravisani, MD PhD principal investigator
Department of Medicine, University of Udine
Patrizia Tulissi, MD study director
Azienda Sanitaria Universitaria Friuli Centrale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNi-BiOTiC® 41167 in people with Urinary Tract Infections and Kidney Transplant Rejection, run by University Hospital, Udine, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infection rates (time frame: from postoperative month 1 to postoperative month 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06825117, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.