Impact of Probiotic Supplementation on Urinary Tract Infections and Clinically Relevant Outcomes of Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Urinary tract infection rates
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
- •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
研究组 & 干预措施
Probiotic group
干预措施: OMNi-BiOTiC® 41167 (Dietary Supplement)
Placebo group
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Urinary tract infection rates
时间窗: 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
时间窗: 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
次要结局
- Gut microbiome(at postoperative month 1 and postoperative month 7)
- Immunosuppression strength(from postoperative month 1 to postoperative month 7)
- Rate of biopsy proven acute rejection(from postoperative month 1 to postoperative month 7)
- Immunosuppression therapy(from postoperative month 1 to postoperative month 7)
- Kidney graft function(from postoperative month 1 to postoperative month 7)
- Bladder microbiome(at postoperative month 1 and postoperative month 7)
研究者
Umberto Baccarani
Prof, MD PhD FEBS
University Hospital, Udine, Italy