Evidence map›Paper›PMID 31454425›Full record

ArticleLetters in applied microbiology2019

Probiotic survival during a multi-layered tablet development as tested in a dynamic, computer-controlled in vitro model of the stomach and small intestine (TIM-1).

K Venema, J Verhoeven, S Verbruggen, L Espinosa, S Courau

Abstract read
In one paragraph

Article in Letters in applied microbiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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.

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

16 citing papers in PubMed.

  1. Trial
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  5. Review
  6. Article
  7. Article
  8. Review
  9. The role ofFood science and biotechnology · 2024
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
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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.

K VenemaDepartment of Human Biology, Centre for Healthy Eating & Food Innovation (HEFI), School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands.ORCID https://orcid.org/0000-0001-7046-5127
J VerhoevenDepartment of Human Biology, Centre for Healthy Eating & Food Innovation (HEFI), School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands.
S VerbruggenDepartment of Human Biology, Centre for Healthy Eating & Food Innovation (HEFI), School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands.
L EspinosaMerck Selbsmedikation GmbH, Darmstadt, Germany.
S CourauMerck Selbsmedikation GmbH, Darmstadt, Germany.

Funding

Merck Selbsmedikation GmbH , Darmstadt, Germany not applicable
6 · The paper itself

Abstract

The aim of the research was to develop a galenical formulation for the combination of the three probiotic strains Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3 and Bifidobacterium bifidum MF 20/5 that would lead to the presence of a high amount of viable cells in the small intestine, the presumed site of action of these strains. This was tested in a validated, dynamic in vitro model of the stomach and small intestine (TIM-1), simulating human adults after intake of a meal. Experiments were performed both in the gastric compartment of the model, as well as in the complete system (stomach + small intestine). Survival of the strains in an unformulated probiotic powder after transit through the gastric compartment was 5·3% for the bifidobacteria and 1% for L. gasseri. After transit through the complete gastrointestinal tract, this dropped to 2% for bifidobacteria and 0·1% for Lactobacillus. After several rounds of optimization, an enteric-coated tablet was developed that increased the delivery of viable cells reaching the small intestine to 72% (gastric survival) for bifidobacteria, and 53% (gastric) for L. gasseri. Also survival in the small intestine increased by about an order of magnitude. The final galenical formulation was tested in two applications: adults and elderly, both of which have their own physiological parameters. These experiments corroborated the results obtained in the development phase of the project. In conclusion, the developed enteric coating led to a 20- to 40-fold increase in the delivery of viable cells to the small intestine. SIGNIFICANCE AND IMPACT OF THE STUDY: Predictive GI in vitro models are very helpful and reliable tools for the development of new galenical formula containing probiotics, and in the current example helped to deliver >10-fold higher numbers of viable cells to the small intestine, presumably leading to improved functionality of the strains.

Indexed as

AdultAgedBifidobacteriumDrug CompoundingHumansIntestine, SmallLactobacillusMicrobial ViabilityProbioticsStomachTabletsTabletsBifidobacteriumLactobacillusmulti-layered tabletprobioticsurvivalTIM-1

Identifiers

PMID31454425
PMCPMC6856813

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Registered trials

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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.