Evidence map›Paper›PMID 31721790›Full record

Trial reportPloS one2019

Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study.

Ratna Sudha Madempudi, Jayesh J Ahire, Jayanthi Neelamraju, Anirudh Tripathi, Satyavrat Nanal

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 9 pooled it
3.3field-weighted citation impact, top 7% 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

39 citing papers in PubMed, 9 syntheses or guidelines pooled it, 99 citations in OpenAlex.

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  14. Nutrients · 2021
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  18. Probiotics,Metabolism open · 2025
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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 1 institution in 1 country.

Ratna Sudha MadempudiCentre for Research & Development, Unique Biotech Ltd., Alexandria Knowledge Park, Hyderabad, Telangana, India.ORCID 0000-0003-1819-722X
Jayesh J AhireCentre for Research & Development, Unique Biotech Ltd., Alexandria Knowledge Park, Hyderabad, Telangana, India.ORCID 0000-0002-1142-8630
Jayanthi NeelamrajuCentre for Research & Development, Unique Biotech Ltd., Alexandria Knowledge Park, Hyderabad, Telangana, India.
Anirudh TripathiLife Veda Treatment and Research Centre, Worli, Mumbai, India.
Satyavrat NanalNanal Clinic, Anand Bhuvan, Gore wadi, Mahim (W), Mumbai, India.
Biotech Park · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRole of multi-strain probiotic formulations in the management of type 2 diabetes mellitus (T2DM) has rarely been reported. In the present study, the effects of the probiotic formulation, UB0316 (L. salivarius UBLS22, L. casei UBLC42, L. plantarum UBLP40, L. acidophilus UBLA34, B. breve UBBr01, B. coagulans Unique IS2, 5 billion CFU each and fructo-oligosaccharides, 100 mg) in patients with T2DM were assessed.

methodsA total of 79 eligible subjects (18-65 years, on stable metformin therapy) were randomly assigned to receive UB0316 or placebo, twice-a-day for 12 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c), secondary were assessment of blood glucose levels, HOMA-IR (homeostatic model assessment of insulin resistance), insulin, body weight, and blood lipids. Quality of life, vital signs, physical investigations, safety and Physician/Subject's Global assessment were also evaluated.

resultsTwelve week multi-strain probiotic (UB0316) supplementation significantly reduced HbA1c (7.70 ± 0.79%; p = 0.0023) and weight (67.00 ± 8.82 kg; p < 0.001) as compared to placebo (HbA1c: 8.30 ± 1.35%; weight: 67.60 ± 9.46 kg). The changes recorded in fasting blood glucose (FBG), HOMA-IR, insulin, TC, TG, HDL, and LDL levels were however not significantly altered as compared to placebo. No severe adverse events, abnormal vital and physical signs were reported. The quality of life of T2DM was significantly improved.

conclusionsUB0316 significantly improved glycemic control as indicated by the decrease in HbA1c levels. There was also a significant decrease in weight in the probiotic treated subjects as compared to placebo.

Indexed as

AdolescentAdultAgedBiomarkersBlood GlucoseDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansLipidsMaleMiddle AgedProbioticsQuality of LifeYoung AdultBiomarkersBlood GlucoseGlycated HemoglobinLipids

Identifiers

PMID31721790
PMCPMC6853318
OpenAlexW2987787916

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.