PRObiotics for KIdney Transplantation

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

Keywords

ClinConnect Summary

This study is testing whether taking a daily probiotic (OMNi-BiOTiC® 41167) for 6 months after a kidney transplant can lower the risk of urinary tract infections (UTIs) and may also help reduce the chance of the transplanted kidney being rejected. It’s a randomized, double‑blind trial, meaning participants are randomly assigned to receive either the probiotic or a placebo (a harmless look‑alike) and neither they nor their doctors know who is in which group. In addition to UTIs and rejection, researchers will look at how the probiotic affects gut and bladder bacteria, how it might influence immunosuppressive medicines like tacrolimus, and whether it improves gastrointestinal symptoms and overall quality of life. Safety will be monitored by tracking any adverse events.

Who can join? Adults aged 18 to 75 who are about 1 month after a kidney transplant with no major problems during the first post‑transplant month. Key exclusions include kids, people over 75, those with multi‑organ transplants, certain bowel conditions, ongoing infection or rejection, or current probiotic use or allergies to the study ingredients. If eligible, you’ll be randomly assigned to the probiotic or placebo and continue your usual transplant medications. You’ll have regular clinic visits and lab tests for 6 months, provide urine and stool samples, and answer questionnaires about GI symptoms and quality of life, with safety checks at each visit.

Gender

ALL

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