Evidence map›Paper›PMID 32947603›Full record

Trial reportPediatric research2021

Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS Trial.

Paul Fleming, Mark Wilks, Simon Eaton, Nicola Panton, Richard Hutchinson, Abena Akyempon, Pollyanna Hardy, Michael R Millar, Kate Costeloe

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Probiotics in the Prevention and Treatment of Necrotizing Enterocolitis.Pediatric gastroenterology, hepatology & nutrition · 2021
    Review
  8. Impact of ProbioticFrontiers in pediatrics · 2021
    Article
  9. Review
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

9 authors at 6 institutions in 1 country.

Paul FlemingHomerton University Hospital, NHS Foundation Trust, London, UK. Paul.fleming@qmul.ac.uk.
Mark WilksDepartment of Infection, Barts Health NHS Trust, London, UK.
Simon EatonUCL Great Ormond Street Institute of Child Health, University College London, London, UK.
Nicola PantonBlizard Institute, Queen Mary University of London, London, UK.
Richard HutchinsonCentre for Genomics and Child Health, Queen Mary University of London, London, UK.
Abena AkyemponHomerton University Hospital, NHS Foundation Trust, London, UK.
Pollyanna HardyBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Michael R MillarDepartment of Infection, Barts Health NHS Trust, London, UK.
Kate CosteloeHomerton University Hospital, NHS Foundation Trust, London, UK.
Barts Health NHS Trust · GBHomerton University Hospital NHS Foundation Trust · GBQueen Mary University of London · GBCancer Research UK Clinical Trials Unit · GBGenomics (United Kingdom) · GBUniversity College London · GB

Funding

Department of Health
6 · The paper itself

Abstract

backgroundUncertainty remains about the role of probiotics to prevent necrotising enterocolitis (NEC) some of which arises from the variety of probiotic interventions used in different trials, many with no prior evidence of potential efficacy. Mechanistic studies of intestinal barrier function embedded in a large probiotic trial could provide evidence about which properties of probiotics might be important for NEC prevention thus facilitating identification of strains with therapeutic potential.

methodsIntestinal permeability, stool microbiota, SCFAs and mucosal inflammation were assessed from the second postnatal week in babies enrolled to a randomised controlled trial of B. breve BBG-001 (the PiPS trial). Results were compared by allocation and by stool colonisation with the probiotic.

resultsNinety-four preterm babies were recruited across six nested studies. B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation. No measure of intestinal barrier function showed differences. The PiPS trial found no evidence of efficacy to reduce NEC.

conclusionsThat the negative results of the PiPS trial were associated with failure of this probiotic to modify intestinal barrier function supports the possibility that the tests described here have the potential to identify strains to progress to large clinical trials. IMPACT: Uncertainty about the therapeutic role of probiotics to prevent necrotising enterocolitis is in part due to the wide range of bacterial strains with no previous evidence of efficacy used in clinical trials. We hypothesised that mechanistic studies embedded in a probiotic trial would provide evidence about which properties of probiotics might be important for NEC prevention. The finding that the probiotic strain tested, Bifidobacterium breve BBG-001, showed neither effects on intestinal barrier function nor clinical efficacy supports the possibility that these tests have the potential to identify strains to progress to large clinical trials.

Indexed as

Infant, PrematureBifidobacterium breveFemaleHumansInfant, NewbornIntestinal MucosaMalePermeabilityProbiotics

Identifiers

PMID32947603
OpenAlexW3087494443

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.