Evidence map›Paper›PMID 30261008›Full record

Trial reportPloS one2018

Association of metformin administration with gut microbiome dysbiosis in healthy volunteers.

Ilze Elbere, Ineta Kalnina, Ivars Silamikelis, Ilze Konrade, Linda Zaharenko, Kristine Sekace, Ilze Radovica-Spalvina, Davids Fridmanis, Dita Gudra, Valdis Pirags and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04089280 (The Effect of Multi-strain Probiotics on Gastrointestinal Symptoms in Patients With Type 2 Diabetes and Metformin Intolerance. A 32-week Prospective, Single Center, Randomized, Placebo Controlled, Cross-over Clinical Trial.), which is not on this map. Cited by 75 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 2 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT04089280 nacompletednot on this map

The Effect of Multi-strain Probiotics on Gastrointestinal Symptoms in Patients With Type 2 Diabetes and Metformin Intolerance. A 32-week Prospective, Single Center, Randomized, Placebo Controlled, Cross-over Clinical Trial.

TypeinterventionalSponsorMedical University of SilesiaRan2018 to 2021Enrolled37ConditionsDiabetes Mellitus, Type 2, Metformin Adverse ReactionArmsSanprobi Barrier-multispecies probiotic, Placebo Comparator
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 2 syntheses or guidelines pooled it, 134 citations in OpenAlex.

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15 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

11 authors at 2 institutions in 1 country.

Ilze ElbereLatvian Biomedical Research and Study Centre, Riga, Latvia.
Ineta KalninaLatvian Biomedical Research and Study Centre, Riga, Latvia.
Ivars SilamikelisLatvian Biomedical Research and Study Centre, Riga, Latvia.
Ilze KonradeRiga East Clinical University Hospital, Riga, Latvia.
Linda ZaharenkoLatvian Biomedical Research and Study Centre, Riga, Latvia.
Kristine SekaceLatvian Biomedical Research and Study Centre, Riga, Latvia.
Ilze Radovica-SpalvinaLatvian Biomedical Research and Study Centre, Riga, Latvia.
Davids FridmanisLatvian Biomedical Research and Study Centre, Riga, Latvia.
Dita GudraLatvian Biomedical Research and Study Centre, Riga, Latvia.
Valdis PiragsLatvian Biomedical Research and Study Centre, Riga, Latvia.
Janis KlovinsLatvian Biomedical Research and Study Centre, Riga, Latvia.ORCID 0000-0001-8362-5505
Latvian Biomedical Research and Study Centre · LVRiga East University Hospital · LV

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetformin is a widely used first-line drug for treatment of type 2 diabetes. Despite its advantages, metformin has variable therapeutic effects, contraindications, and side effects. Here, for the very first time, we investigate the short-term effect of metformin on the composition of healthy human gut microbiota.

methodsWe used an exploratory longitudinal study design in which the first sample from an individual was the control for further samples. Eighteen healthy individuals were treated with metformin (2 × 850 mg) for 7 days. Stool samples were collected at three time points: prior to administration, 24 hours and 7 days after metformin administration. Taxonomic composition of the gut microbiome was analyzed by massive parallel sequencing of 16S rRNA gene (V3 region).

resultsThere was a significant reduction of inner diversity of gut microbiota observed already 24 hours after metformin administration. We observed an association between the severity of gastrointestinal side effects and the increase in relative abundance of common gut opportunistic pathogen Escherichia-Shigella spp. One week long treatment with metformin was associated with a significant decrease in the families Peptostreptococcaceae and Clostridiaceae_1 and four genera within these families.

conclusionsOur results are in line with previous findings on the capability of metformin to influence gut microbiota. However, for the first time we provide evidence that metformin has an immediate effect on the gut microbiome in humans. It is likely that this effect results from the increase in abundance of opportunistic pathogens and further triggers the occurrence of side effects associated with the observed dysbiosis. An additional randomized controlled trial would be required in order to reach definitive conclusions, as this is an exploratory study without a placebo control arm. Our findings may be further used to create approaches that improve the tolerability of metformin.

Indexed as

AdultBacteriaClostridiaceaeDNA, BacterialDNA, RibosomalDrug Administration ScheduleDysbiosisFemaleGastrointestinal MicrobiomeHealthy VolunteersHigh-Throughput Nucleotide SequencingHumansLongitudinal StudiesMaleMetforminPeptostreptococcusDNA, BacterialDNA, RibosomalMetforminRNA, Ribosomal, 16S

Identifiers

PMID30261008
PMCPMC6160085
OpenAlexW2893759281

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.