Evidence map›Paper›PMID 24260122›Full record

Trial reportPloS one2013

Oral delivery of a probiotic induced changes at the nasal mucosa of seasonal allergic rhinitis subjects after local allergen challenge: a randomised clinical trial.

Kamal Ivory, Andrew M Wilson, Prasanna Sankaran, Marta Westwood, Justin McCarville, Claire Brockwell, Allan Clark, Jack R Dainty, Laurian Zuidmeer-Jongejan, Claudio Nicoletti

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01123252 (Evaluation of the Effect of Yoghurt-type Drink on Symptoms of Subjects Suffering Seasonal Allergic Rhinitis), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT01123252 phase2completednot on this map

Evaluation of the Effect of Yoghurt-type Drink on Symptoms of Subjects Suffering Seasonal Allergic Rhinitis (SAR) [Rhinitis 2]

TypeinterventionalSponsorUniversity of East AngliaRan2010 to 2011Enrolled60ConditionsSeasonal Affective Rhinitis, Asthma, Grass AllergyArmsLactobacillus casei Shirota (LcS), Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 28 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. IL-1Mediators of inflammation · 2023
    Review
  5. Article
  6. Review
  7. The Beneficial Role of ProbioticFrontiers in immunology · 2022
    Review
  8. Article
  9. Article
  10. Review
  11. Microbiome and Allergic Diseases.Frontiers in immunology · 2018
    Review
  12. Article
  13. Article
  14. Article
  15. 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

10 authors at 3 institutions in 2 countries.

Kamal IvoryGut Health and Food Safety Strategic Programme, Institute of Food Research, Colney, Norwich, United Kingdom.
Andrew M Wilson
Prasanna Sankaran
Marta Westwood
Justin McCarville
Claire Brockwell
Allan Clark
Jack R Dainty
Laurian Zuidmeer-Jongejan
Claudio Nicoletti
Quadram Institute · GBUniversity of East Anglia · GBAcademic Medical Center · NL

Funding

Biotechnology and Biological Sciences Research Council BB/J004529/1
6 · The paper itself

Abstract

objectiveTo determine effects of probiotic consumption on clinical and immunological parameters of seasonal allergic rhinitis (SAR) in an out-of-season single nasal allergen challenge.

methodsIn a study registered at ClinicalTrials.Gov (NCT01123252), a 16-week dietary intervention was undertaken in 60 patients with allergic rhinitis (>16 years old). Using a double-blinded, placebo-controlled anonymised design, the patients were divided equally into two groups. One group was given a dairy drink containing Lactobacillus casei Shirota to ingest daily while the other consumed a similar drink without bacteria. Participants attended the clinic on two consecutive days before the intervention and then again at the end of the study period. On the first day of each 2-day visit, following clinical examination, assessments were made of total nasal symptoms scores and peak nasal inspiratory flow. Nasal scrapings, nasal lavage and blood were collected for laboratory analyses of cellular phenotypes, soluble mediator release and in vitro responses to pollen allergen. These procedures were repeated 24 hours following nasal allergen challenge.

resultsPrior to and following intervention there were no detectable differences between study groups in measured clinical outcome. After intervention, there were differences between groups in their percentages of CD86+ epithelial cells (p = 0.0148), CD86+CD252+ non-epithelial cells (p = 0.0347), sIL-1RII release (p = 0.0289) and IL-1β (p = 0.0224) levels at the nasal mucosa. Delivery of probiotic also suppressed production of sCD23 (p = 0.0081), TGF-β (p = 0.0283) and induced increased production of IFN-γ (p = 0.0351) in supernatants of cultured peripheral blood. CONCLUSIONS & CLINICAL RELEVANCE: This study did not show significant probiotic-associated changes with respect to the primary clinical endpoint. An absence of overt clinical benefit may be due to an inability of single nasal challenges to accurately represent natural allergen exposure. Nevertheless, oral delivery of probiotics produced changes of the immunological microenvironment at the nasal mucosa in individuals affected by SAR.

trial registrationClinicalTrials.Gov NCT01123252.

Indexed as

AllergensLacticaseibacillus caseiAdministration, OralAdultAntigens, CDDouble-Blind MethodFemaleHumansInterferon-gammaInterleukin-1betaMaleMiddle AgedNasal MucosaProbioticsRhinitis, Allergic, SeasonalTransforming Growth Factor betaAllergensAntigens, CDIFNG protein, humanIL1B protein, humanInterferon-gammaInterleukin-1betaTransforming Growth Factor beta

Identifiers

PMID24260122
PMCPMC3829814
OpenAlexW2051279576

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.