Evidence map›Paper›PMID 31054010›Full record

Trial reportInflammopharmacology2019

A randomised, double-blind, placebo-controlled trial of a multi-strain probiotic in patients with asymptomatic ulcerative colitis and Crohn's disease.

Ingvar Bjarnason, Guy Sission, Bu'Hussaine Hayee

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Inflammopharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 113 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 8 pooled it
14.3field-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

113 citing papers in PubMed, 8 syntheses or guidelines pooled it, 201 citations in OpenAlex.

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  7. Probiotics for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
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  8. Probiotics for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
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53 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

3 authors at 2 institutions in 1 country.

Ingvar BjarnasonDepartments of Gastroenterology At King'S College Hospital, Denmark Hill, London, SE59RS, UK. Ingvar.Bjarnason@nhs.net.ORCID http://orcid.org/0000-0002-5520-492X
Guy SissionDarent Valley Hospital, Darent Wood Road, Dartford, Kent, UK.
Bu'Hussaine HayeeDepartments of Gastroenterology At King'S College Hospital, Denmark Hill, London, SE59RS, UK.
King's College Hospital · GBDarent Valley Hospital · GB

Funding

Symprove Ltd King's College Hospital
6 · The paper itself

Abstract

backgroundThere is considerable interest in the possible importance of the gut microflora in the pathophysiology of the inflammatory bowel diseases (IBD) ulcerative colitis (UC) and Crohn's disease (CD). Probiotics offer a potential adjuvant treatment in these patients by modifying the intestinal milieu, but reports of their efficacy are conflicting.

aimsTo assess the efficacy of a multi-strain probiotic (Symprove™, Symprove Ltd, Farnham, United Kingdom) in quality of life issues and intestinal inflammation in patients with asymptomatic UC and CD.

methodsA single-centre, randomised, double-blind, placebo-controlled trial of adult patients with asymptomatic IBD. Patients received 4 weeks of treatment with the probiotic or placebo (1 ml/kg/day). The primary efficacy measure was the difference in change in the IBD Quality of Life Questionnaire results (QOL) between probiotic vs. placebo at week 4. Secondary outcome measures included analyses of the change in laboratory findings, including faecal calprotectin (FCAL).

resultsOver 500 patients were recruited to the study and 81 and 61 patients with UC and CD, respectively were randomised and completed the study. There were no significant differences in IBD-QOL scores between placebo and the probiotic groups. Similarly, there were no significant changes observed in the laboratory data. However, the differences in FCAL between patients with UC before and after probiotics versus placebo approached statistical significance with a p value of 0.076. Post-hoc analyses showed that the FCAL levels were significantly (p < 0.015) reduced in the UC patients receiving the probiotic as opposed to placebo. No significant changes were seen in CD. No serious adverse events were observed.

conclusionThis multi-strain probiotic is associated with decreased intestinal inflammation in patients with UC, but not in CD and is well tolerated. Further research is required to see if the probiotic reduces the incidence of clinical relapses in asymptomatic IBD patients.

Indexed as

AdultColitis, UlcerativeCrohn DiseaseDouble-Blind MethodFemaleHumansInflammationIntestinesLeukocyte L1 Antigen ComplexMaleMiddle AgedProbioticsQuality of LifeLeukocyte L1 Antigen ComplexAlternative therapyComplementaryIBDProbiotic

Identifiers

PMID31054010
PMCPMC6554453
OpenAlexW2942731295

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.