NCT07884084|Completed
Effect of Probiotics on Immunosuppressant Therapy in Kidney Transplant Recipients
PITON
Probiotics for Immunosuppressant Therapy Optimization
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PITON
Probiotics for Immunosuppressant Therapy Optimization
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Ministry of Health, Italy
interventional
40
1 country
1
Study Start
June 18, 2025
Actual (reported)Primary Completion
October 3, 2025
Actual (reported)Study Completion
October 3, 2025
Actual (reported)People who receive a donor kidney must take drugs to prevent their bodies from attacking the new organ. These drugs are called immunosuppressants. Probiotics are beneficial microbes that support gut health. They are often given to reduce immunosuppressant toxicity for the gut. The goal of this clinical trial is to learn if probiotics change the levels of immunosuppressants in the blood in patients who have received a kidney transplant. The main question it aims to answer is:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 3, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2025
Actual (reported)October 3, 2025
Actual (reported)October 3, 2025
Actual (reported)October 6, 2026
Actual (reported)October 20, 2026
Actual (reported)Changes in immunosuppressant drug blood levels
Cyclosporin A, tacrolimus and sirolimus will be measured using CMIA (Chemiluminescent Microparticle Immunoassay); everolimus using QMS (Quantitative Microsphere System); mycophenolic acid using CEDIA (Cloned Enzyme Donor Immunoassay); and prednisolone using ELISA (Enzyme-Linked Immunosorbent Assay).
Immunosuppressant blood levels will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of high-sensitivity C-reactive protein (hsCRP)
High-sensitivity C-reactive protein (hsCRP) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Patients first receive a placebo, followed by probiotics after a washout period
Patients first receive probiotic, followed by placebo after a washout period
A multistrain probiotic mixture, formulated in capsules for oral administration, containing L. plantarum, L. rhamnosus, L. acidophilus, L. casei, S. thermophilus, B. lactis and an extract of the plant Boswellia serrata. Capsules also contain microcrystalline cellulose, soy lecithin and magnesium dioxide as excipients.
AOU Federico II
Naples, 80131, Italy
Huang HW, Chen MJ. Exploring the Preventive and Therapeutic Mechanisms of Probiotics in Chronic Kidney Disease through the Gut-Kidney Axis. J Agric Food Chem. 2024 Apr 17;72(15):8347-8364. doi: 10.1021/acs.jafc.4c00263. Epub 2024 Apr 4.
Chung S, Barnes JL, Astroth KS. Gastrointestinal Microbiota in Patients with Chronic Kidney Disease: A Systematic Review. Adv Nutr. 2019 Sep 1;10(5):888-901. doi: 10.1093/advances/nmz028.
Mauro Cataldi, MD, PhD
Federico II University of Naples, ITALY
40 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2026
First Posted
October 20, 2026
Study Start
June 18, 2025
Actual (reported)The Effect of Emotion-Focused Intervention on Emotion Regulation and Well-Being of Individuals With Transplantation
Changes in the blood levels of interleukin-1β (IL-1β)
Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of interleukin-6 (IL-6)
Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood levels of tumor necrosis factor-α (TNF-α)
Tumor necrosis factor-α (TNF-α) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Changes in the blood urea nitrogen (BUN)
BUN will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Placebo capsules contain only the excipients found in the probiotic preparation (microcrystalline cellulose, soy lecithin and magnesium dioxide). They are indistinguishable from probiotic capsules.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Chen Z, Chang X, Ye Q, Gao Y, Deng R. Kidney transplantation and gut microbiota. Clin Kidney J. 2024 Aug 14;17(8):sfae214. doi: 10.1093/ckj/sfae214. eCollection 2024 Aug.
Di Renzo T, Reale A, Nazzaro S, Iovanna D, Evangelista D, Gautam V, Guida B, Carrano R, Cataldi M. Impact of Probiotics, Prebiotics and Synbiotics Supplementation in Chronic Kidney Disease: A Comprehensive Review of Clinical Trials. Nutrients. 2026 Apr 8;18(8):1176. doi: 10.3390/nu18081176.
Manes A, Di Renzo T, Dodani L, Reale A, Gautiero C, Di Lauro M, Nasti G, Manco F, Muscariello E, Guida B, Tarantino G, Cataldi M. Pharmacomicrobiomics of Classical Immunosuppressant Drugs: A Systematic Review. Biomedicines. 2023 Sep 18;11(9):2562. doi: 10.3390/biomedicines11092562.
Primary Completion
October 3, 2025
Actual (reported)Study Completion
October 3, 2025
Actual (reported)Last Updated
October 20, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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