Evidence map›Paper›PMID 30076458›Full record

Trial reportEuropean journal of nutrition2019

An open-label, randomized, placebo-controlled study on the effectiveness of a novel probiotics administration protocol (ProbiotiCKD) in patients with mild renal insufficiency (stage 3a of CKD).

Mariadelina Simeoni, Maria Lucia Citraro, Annamaria Cerantonio, Francesca Deodato, Michele Provenzano, Paola Cianfrone, Maria Capria, Silvia Corrado, Emanuela Libri, Alessandro Comi and 6 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of nutrition, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 47 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 5 pooled it
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 5 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Biotic Supplements in Patients With Chronic Kidney Disease: Meta-Analysis of Randomized Controlled Trials.Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
  13. Gut-kidney axis: Dysbiosis and renal disease.World journal of nephrology · 2026
    Review
  14. Article
  15. Microbiota-gut-kidney axis in health and renal disease.International journal of biological sciences · 2026
    Review
  16. Review
  17. Review
  18. Article
  19. Chemotherapy-related cognitive impairment and kidney dysfunction.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 1 institution in 1 country.

Mariadelina SimeoniNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy. adelina.simeoni@unicz.it.
Maria Lucia CitraroNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Annamaria CerantonioNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Francesca DeodatoNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Michele ProvenzanoNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Paola CianfroneNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Maria CapriaNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Silvia CorradoNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Emanuela LibriNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Alessandro ComiNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Arturo PujiaClinical Nutrition Unit, 'Magna Graecia' University Hospital, 88100, Catanzaro, CZ, Italy.
Ludovico AbenavoliDigestive Physiopathology Unit, 'Magna Graecia' University Hospital, 88100, Catanzaro, CZ, Italy.
Michele AndreucciNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Massimo Cocchi"Paolo Sotgiu" Institute for Research in Quantitative and Quantum Psychiatry and Cardiology, LUdeS, Lugano, Switzerland.
Tiziana MontalciniClinical Nutrition Unit, 'Magna Graecia' University Hospital, 88100, Catanzaro, CZ, Italy.
Giorgio FuianoNephrology Unit, Department of Surgical and Medical Science, 'Magna Graecia' University Hospital, Viale Europa, Germaneto Area, 88100, Catanzaro, CZ, Italy.
Magna Graecia University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeGut dysbiosis has been described in advanced, but not in initial stages of CKD. Considering the relevant impact of gut dysbiosis on renal and cardiovascular risk, its diagnosis and treatment are clinically relevant.

methodsWe designed, open-label, placebo-controlled intervention study (ProbiotiCKD) to evaluate gut microbiota metabolism in a cohort of KDIGO CKD patients (n = 28) at baseline and after a randomly assigned treatment with probiotics or placebo. Gut microbiota status was evaluated on:.

resultsBasal mean fecal Lactobacillales and Bifidobacteria concentrations were abnormally low in both groups, while urinary indican and 3-MI levels were, indicating a mixed (fermentative and putrefactive) dysbiosis. After treatment, mean fecal Lactobacillales and Bifidobacteria concentrations were increased, only in the probiotics group (p < 0.001). Conversely, mean urinary indican and 3-MI levels only in the group treated with probiotics (p < 0.001). Compared to placebo group, significant improvements of C-reactive protein (p < 0.001), iron (p < 0.001), ferritin (p < 0.001), transferrin saturation (p < 0.001), β2-microglobulin (p < 0.001), serum iPTH and serum calcium were observed only in the probiotics group.

conclusionsProbiotiCKD is the first intervention study demonstrating that an intestinal mixed dysbiosis is present even in early CKD stage and can be effectively corrected by the novel mode of administration of high-quality probiotics with improvement of inflammatory indices, iron status and iPTH stabilization.

Indexed as

Clinical ProtocolsDysbiosisFemaleGastrointestinal MicrobiomeHumansMaleMiddle AgedProbioticsRenal InsufficiencyTreatment OutcomeChronic kidney diseaseDysbiosisGut microbiotaProbioticsUremia

Identifiers

PMID30076458
PMCPMC6647244
OpenAlexW2886394193

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.