Evidence map›Paper›PMID 25147806›Full record

Trial reportBioMed research international2014

Randomized controlled trial of strain-specific probiotic formulation (Renadyl) in dialysis patients.

Ranganathan Natarajan, Bohdan Pechenyak, Usha Vyas, Pari Ranganathan, Alan Weinberg, Peter Liang, Mary C Mallappallil, Allen J Norin, Eli A Friedman, Subodh J Saggi

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BioMed research international, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 78 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 13 pooled it
–field-weighted citation impact
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.

NCT03877081 phase3unknown statusnot on this mapstarted 2019, after this paper: background citation

Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients, Randomized Control Trial

TypeinterventionalSponsorHospital Civil de GuadalajaraRan2019 to 2023Enrolled90ConditionsAcute Kidney Injury, Probiotics, SepsisArmsProbiotics, Placebo
NCT04527640 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Effects of Synbiotics Supplementation on the Concentration of the Uremic Toxin Indoxyl Sulfate, Symptoms of Constipation, and Constipation-related Quality of Life in End-stage Renal Disease Patients Undergoing Hemodialysis

TypeinterventionalSponsorIndonesia UniversityRan2020 to 2021Enrolled60ConditionsConstipation, End Stage Renal Disease on DialysisArmsSynbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg, Placebo
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  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
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  19. Gut-kidney axis: Dysbiosis and renal disease.World journal of nephrology · 2026
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18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Ranganathan NatarajanKibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.
Bohdan PechenyakKibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.ORCID 0000-0002-6961-5885
Usha VyasKibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.ORCID 0000-0002-1860-9872
Pari RanganathanKibow Biotech, Inc., 4781 West Chester Pike, Newtown Square, PA 19073, USA.ORCID 0000-0002-0530-9045
Alan WeinbergMount Sinai School of Medicine, New York, NY 10029, USA.ORCID 0000-0002-1312-2897
Peter LiangDownstate Medical Center, State University of NY, New York, NY 11203, USA.ORCID 0000-0003-3672-9293
Mary C MallappallilDownstate Medical Center, State University of NY, New York, NY 11203, USA.
Allen J NorinDownstate Medical Center, State University of NY, New York, NY 11203, USA.
Eli A FriedmanDownstate Medical Center, State University of NY, New York, NY 11203, USA.
Subodh J SaggiDownstate Medical Center, State University of NY, New York, NY 11203, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrimary goal of this randomized, double-blind, placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins. Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress.

methodsTwo 2-month treatment periods separated by 2-month washout and crossover, with physical examinations, venous blood testing, and quality of life questionnaires completed at each visit. Data were analyzed with SAS V9.2.

results22 subjects (79%) completed the study. Observed trends were as follows (none reaching statistical significance): decline in WBC count (-0.51 × 10(9)/L, P = 0.057) and reductions in levels of C-reactive protein (-8.61 mg/L, P = 0.071) and total indoxyl glucuronide (-0.11 mg%, P = 0.058). No statistically significant changes were observed in other uremic toxin levels or measures of QOL.

conclusionsRenadyl appeared to be safe to administer to ESRD patients on hemodialysis. Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease. Efficacy could not be confirmed definitively, primarily due to small sample size and low statistical power-further studies are warranted.

Indexed as

AdultAgedBiomarkersC-Reactive ProteinCross-Over StudiesDouble-Blind MethodFemaleHumansInflammationKidney Failure, ChronicMaleMiddle AgedOxidative StressProbioticsQuality of LifeRenal DialysisBiomarkersC-Reactive Protein

Identifiers

PMID25147806
PMCPMC4132402

What OpenQuestion holds

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Registered trials

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.