An interventional study of Probiotic formulation and Placebo in Kidney Transplantation and Kidney Transplantation Recipients, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
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:
Study participants will be patients with kidney transplant. At different times, each participant will take either probiotics or look-alike capsules with no probiotics. Researchers will compare the levels of immunosuppressant in the blood when participants take the probiotics with those when they take the capsules with no microbes.
Study participants will have to:
Federico II University is the lead sponsor of 365 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Patients first receive a placebo, followed by probiotics after a washout period
Other: Probiotic formulation · Other: Placebo
Patients first receive probiotic, followed by placebo after a washout period
Other: Probiotic formulation · Other: Placebo
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.
Placebo capsules contain only the excipients found in the probiotic preparation (microcrystalline cellulose, soy lecithin and magnesium dioxide). They are indistinguishable from probiotic capsules.
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).
Time frame: 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 in mg/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Time frame: 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.
Changes in the blood levels of interleukin-1β (IL-1β)
Interleukin-1β (IL-1β) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Time frame: 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-6 (IL-6) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Time frame: 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 in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
Time frame: 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)
Blood urea nitrogen (BUN) will be measured in mg/dL using a standard clinical chemistry analyzer.
Time frame: 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.
Changes in serum creatinine
Serum creatinine will be measured in mg/dL using a standard clinical chemistry analyzer.
Time frame: Serum creatinine 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 Estimated Glomerular Filtration Rate (eGFR)
eGFR will be measured in ml/min using a standard clinical chemistry analyzer.
Time frame: eGFR 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.
Body weight
Body weight in Kg will be measured using a professional medical scale.
Time frame: Body weight 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
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated as the ratio of body weight to the square of height.
Time frame: Body Mass Index (BMI) 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.
Waist circumference
Waist circumference in cm will be measured using a tape measure.
Time frame: Waist circumference 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.
Total body water
Total body water in Liters will be measured using Bioelectrical Impedance Analysis (BIA).
Time frame: Total body water 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.
Extracellular water
Extracellular water in Liters will be measured using Bioelectrical Impedance Analysis (BIA).
Time frame: Extracellular water 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.
Fat Mass (FM)
Fat Mass (FM) in Kg will be measured using Bioelectrical Impedance Analysis (BIA).
Time frame: Fat Mass (FM) 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.
Fat Free Mass (FFM)
Fat Free Mass (FFM) in Kg will be measured using Bioelectrical Impedance Analysis (BIA).
Time frame: Fat Free Mass (FFM) 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.
Phase Angle (PhA)
Phase Angle (PhA) will be calculated using the resistance and reactance values measured with BIA.
Time frame: Phase Angle (PhA) 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.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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