Evidence map›Paper›PMID 26654906›Full record

Trial reportBMC complementary and alternative medicine2015

Effect of microbial cell preparation on renal profile and liver function among type 2 diabetics: a randomized controlled trial.

Somayyeh Firouzi, Barakatun-Nisak Mohd-Yusof, Hazreen-Abd Majid, Amin Ismail, Nor-Azmi Kamaruddin

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC complementary and alternative medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01752803 (A Double-blind, Randomized Placebo-controlled Parallel Group Study of Probiotics as an Adjuvant Therapy for Individuals With Type 2 Diabetes Mellitus), which is not on this map. Cited by 25 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 11 pooled it
1.1field-weighted citation impact, top 21% 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.

NCT01752803 naunknown statusnot on this map

A Double-blind, Randomized Placebo-controlled Parallel Group Study of Probiotics as an Adjuvant Therapy for Individuals With Type 2 Diabetes Mellitus

TypeinterventionalSponsorUniversiti Kebangsaan Malaysia Medical CentreRan2012 to 2015Enrolled100ConditionsType 2 Diabetes Mellitus, Obesity, Hypertension, HyperlipidemiaArmsProbiotic, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 11 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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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

5 authors at 3 institutions in 1 country.

Somayyeh FirouziDepartment of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia. firouzi.som@gmail.com.
Barakatun-Nisak Mohd-YusofDepartment of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia. bnisak@upm.edu.my.
Hazreen-Abd MajidCentre for Population Health and Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia. hazreen@ummc.edu.my.
Amin IsmailDepartment of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia. aminis@upm.edu.my.
Nor-Azmi KamaruddinDepartment of Medicine, Faculty of Medicine, University Kebangsaan Malaysia, Kuala Lumpur, Malaysia. dr.nor.azmi@gmail.com.
Universiti Putra Malaysia · MYUniversity Kebangsaan Malaysia Medical Centre · MYUniversity of Malaya · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively. However, its effect on renal profile and liver function among type 2 diabetic individuals has not been fully understood. To investigate the effect of microbial cell preparation on renal profile and liver function tests among type 2 diabetic individuals.

methodsA randomized, double-blind, parallel-group, controlled clinical trial was conducted on a total of 136 type 2 diabetics age 30-70 years old in a teaching hospital in Kuala Lumpur, Malaysia. Subjects were randomly assigned to receive microbial cell preparation (N = 68) or a placebo (N = 68) for 12 weeks. The outcomes measured at baseline, week 6, and week 12 and included changes in renal profile (Sodium, Potassium, Urea, Creatinine, Glomerular Filtration Rate), and liver function tests (Albumin, Total Protein, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase). Intention to treat (ITT) analysis was performed on all the recruited subjects, while per protocol (PP) analysis was conducted on those who completed the trial with good compliance.

resultThe urea levels significantly declined in the probiotic group. Serum urea levels reduced from 4.26 mmol/L to 4.04 mmol/L in Probiotic Group while it increased in Placebo Group from 4.03 mmol/L to 4.24 mmol/L. These changes were significant between groups in ITT analysis (p = 0.018). Other parameters did not change significantly between groups.

conclusion12 weeks supplementation with daily dosage of 6 × 10(10) Colony Forming Units of multi-strain microbial cell preparation significantly improved urea levels.

trial registration( CLINICAL TRIALS: # NCT01752803).

Indexed as

AdultAgedAlanine TransaminaseAspartate AminotransferasesDiabetes Mellitus, Type 2Double-Blind MethodFecesFemaleHumansKidneyLactobacillaceaeLiverMaleMiddle AgedProbioticsAlanine TransaminaseAspartate Aminotransferases

Identifiers

PMID26654906
PMCPMC4676823
OpenAlexW2191690914

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.