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Trial · NCT07884084

Effect of Probiotics on Immunosuppressant Therapy in Kidney Transplant Recipients

NCT07884084, Not applicable, Completed, Federico II University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effect of Probiotics on Immunosuppressant Therapy in Kidney Transplant Recipients. Trials, record NCT07884084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07884084

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effect of Probiotics on Immunosuppressant Therapy in Kidney Transplant Recipients
NCT number
NCT07884084
Status
Completed
Phases
Not applicable
Enrollment
40 participants, actual
Lead sponsor
Federico II University
Conditions
Kidney Transplantation, Kidney Transplantation Recipients
Interventions
Probiotic formulation, Placebo
First posted
2026-10-20
Last updated
2026-10-20

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChanges in immunosuppressant drug blood levels
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.
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).
SecondaryChanges 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.
High-sensitivity C-reactive protein (hsCRP) will be measured in mg/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges 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.
Interleukin-1β (IL-1β) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges 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.
Interleukin-6 (IL-6) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges 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.
Tumor necrosis factor-α (TNF-α) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges 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.Blood urea nitrogen (BUN) will be measured in mg/dL using a standard clinical chemistry analyzer.
SecondaryChanges in serum creatinine
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.
Serum creatinine will be measured in mg/dL using a standard clinical chemistry analyzer.
SecondaryChanges in Estimated Glomerular Filtration Rate (eGFR)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.eGFR will be measured in ml/min using a standard clinical chemistry analyzer.
SecondaryBody weight
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 weight in Kg will be measured using a professional medical scale.
SecondaryBody Mass Index (BMI)
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.
Body Mass Index (BMI) will be calculated as the ratio of body weight to the square of height.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
31165878BACKGROUNDPubMed
37761003BACKGROUNDPubMed
38571475BACKGROUNDPubMed
39170931BACKGROUNDPubMed
42074989BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07884084

GET https://conductscience.org/api/trials/v1/NCT07884084/registered