PRObiotics for KIdney Transplantation

Launched by UNIVERSITY HOSPITAL, UDINE, ITALY · Feb 7, 2025

Keywords

ClinConnect Summary

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 fu...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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