Evidence map›Paper›PMID 21327023›Full record

ReviewGut microbes

Safety assessment of probiotics for human use.

Mary Ellen Sanders, Louis M A Akkermans, Dirk Haller, Cathy Hammerman, James Heimbach, Gabriele Hörmannsperger, Geert Huys, Dan D Levy, Femke Lutgendorff, David Mack and 3 more

Open access · bronzeAbstract readReview
In one paragraph

Review in Gut microbes. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 330 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
330citing papers in PubMed, 7 pooled it
30.8field-weighted citation impact, top 1% 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

330 citing papers in PubMed, 7 syntheses or guidelines pooled it, 758 citations in OpenAlex.

  1. Pooled it
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  11. Gut microbes · 2026
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
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  20. Cheonggukjang-DerivedMetabolites · 2026
    Article

270 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

13 authors at 6 institutions in 6 countries.

Mary Ellen SandersDairy and Food Culture Technologies, Centennial, CO, USA. mes@mesanders.com
Louis M A Akkermans
Dirk Haller
Cathy Hammerman
James Heimbach
Gabriele Hörmannsperger
Geert Huys
Dan D Levy
Femke Lutgendorff
David Mack
Phoukham Phothirath
Gloria Solano-Aguilar
Elaine Vaughan
Creation Technologies (United States) · USGhent University Hospital · BEGregor Mendel Institute of Molecular Plant Biology · ATLeibniz-Institute for Food Systems Biology at the Technical University of Munich · DEShaare Zedek Medical Center · ILUniversity Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in certain vulnerable populations, including infants with undeveloped immune function. A few reports about negative probiotic effects have surfaced, the significance of which would be better understood with more complete understanding of the mechanisms of probiotic interaction with the host and colonizing microbes. Use of readily available and low cost genomic sequencing technologies to assure the absence of genes of concern is advisable for candidate probiotic strains. The field of probiotic safety is characterized by the scarcity of studies specifically designed to assess safety contrasted with the long history of safe use of many of these microbes in foods.

Indexed as

BacteriaFood SafetyAnimalsConsumer Product SafetyDrug TherapyHumansIntestinesProbioticsRandomized Controlled Trials as Topicantibiotic resistancebifidobacteriumFDAHealth CanadalactobacillusprobioticPROSAFEQPSsafety

Identifiers

PMID21327023
PMCPMC3023597
OpenAlexW2019795434

What OpenQuestion holds

Textmetadata
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.