Evidence map›Paper›PMID 21453880›Full record

Trial reportJournal of Crohn's & colitis2011

A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis.

Signe Wildt, Inge Nordgaard, Ulla Hansen, Elke Brockmann, Jüri J Rumessen

RetractedErratum issued Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT00268164 (Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis), which is not on this map. Cited by 64 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 14 pooled it
12.5field-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.

NCT00268164 phase2terminatednot on this map

Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

TypeinterventionalSponsorHvidovre University HospitalRan2004 to 2007Enrolled48ConditionsUlcerative ColitisArmslactobacilus acidophilus & bifidobacterium animalis/lactis
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 14 syntheses or guidelines pooled it, 135 citations in OpenAlex.

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  7. Guideline
  8. Probiotics for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
    Pooled it
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Expression of concern · 2022-01-24Civil Proceedings · Concerns/Issues about Data · Concerns/Issues about Results and/or Conclusions · Legal Reasons and/or Threats · · See also: https://doi.org/10.1093/ecco-jcc/jjab225 Journal was previously published by Elsevier until 2015.
  • Commented on by
  • Erratum issued
5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Signe WildtDept. of Medical Gastroenterology, Hvidovre Hospital, University Hospital of Copenhagen, Denmark. siw@dadlnet.dk
Inge Nordgaard
Ulla Hansen
Elke Brockmann
Jüri J Rumessen
Hvidovre Hospital · DKChr. Hansen (Denmark) · DKGentofte Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsTo investigate the clinical effect of treatment with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 (Probio-Tec AB-25) to maintain remission in patients with ulcerative colitis.

methodsPatients with left-sided ulcerative colitis in remission - including proctitis and at least one relapse within the last year were randomised (2:1) in a double-blind placebo-controlled study to Probio-Tec AB-25 or placebo for 52 weeks. The patients were evaluated clinically, endoscopically and histologically at entry and if relapsing. No other medication for ulcerative colitis than the study drug was allowed during the study. Primary endpoint was maintenance of clinical remission, secondary endpoints comparisons of days to relapse, and safety and tolerability of the study drug. The concentrations of the probiotic bacterial strains in stool were analysed in a subset of patients.

resultsThirty-two patients were randomised. Twenty patients received Probio-Tec AB-25 and twelve patients received placebo. Five patients (25%) in the Probio-Tec AB-25 group and one patient (8%) in the placebo group maintained remission after 1 year of treatment (p=0.37). The median time to relapse was 125.5days (range 11-391 days) in the probiotic group and 104 days (range 28-369 days) in the placebo group respectively, (p=0.683). Probio-Tec AB-25 was overall well tolerated.

conclusionsIn this small randomised placebo-controlled trial no significant clinical benefit of Probio-Tec AB-25 could be demonstrated in comparison with placebo for maintaining remission in patients with left-sided ulcerative colitis. A difference may be achieved in larger studies, but the clinical significance of this would be questionable. This study was registered in ClinicalTrial.gov (NCT00268164).

Indexed as

BifidobacteriumLactobacillus acidophilusAdultAgedColitis, UlcerativeDisease-Free SurvivalDouble-Blind MethodFemaleHumansMaleMiddle AgedProbioticsProspective StudiesTreatment OutcomeYoung Adult

Identifiers

PMID21453880
OpenAlexW2154367184

What OpenQuestion holds

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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.