Evidence map›Paper›PMID 15479682›Full record

Trial reportGut2004

Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine.

W Kruis, P Fric, J Pokrotnieks, M Lukás, B Fixa, M Kascák, M A Kamm, J Weismueller, C Beglinger, M Stolte and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00848003 (Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics), which is not on this map. Cited by 467 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
467citing papers in PubMed, 10 pooled it
80.0field-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.

NCT00848003 phase1completednot on this mapstarted 2009, after this paper: background citation

Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics

TypeinterventionalSponsorGeorgetown UniversityRan2009 to 2011Enrolled40ConditionsAdults on AntibioticsArmsBifidobacterium animalis subsp. lactis strain BB-12, Placebo
3 · Its place in the literature

Who cites it

467 citing papers in PubMed, 10 syntheses or guidelines pooled it, 1,253 citations in OpenAlex.

  1. Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025
    Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Guideline
  9. Probiotics for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
    Pooled it
  10. Probiotics for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
    Pooled it
  11. Trial
  12. Trial
  13. Review
  14. Review
  15. Article
  16. Review
  17. Living Microbial Drugs.Chemistry (Weinheim an der Bergstrasse, Germany) · 2026
    Review
  18. Review
  19. Article
  20. Review

407 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

12 authors at 10 institutions in 6 countries.

W KruisEvangelisches Krankenhaus Kalk, University of Cologne, Germany. ansorg@evkk.de.
P Fric
J Pokrotnieks
M Lukás
B Fixa
M Kascák
M A Kamm
J Weismueller
C Beglinger
M Stolte
C Wolff
J Schulze
Ardeypharm (Germany) · DECharles University · CZBayreuth Medical Center · DEKoblenz University of Applied Sciences · DEMilitary University Hospital Prague · CZPauls Stradiņš Clinical University Hospital · LVSt Mark's Hospital · GBTH Köln - University of Applied Sciences · DEUniversity Hospital of Basel · CHVysoká škola manažmentu, City University of Seattle · SK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsEvidence exists for the pathogenic role of the enteric flora in inflammatory bowel disease. Probiotics contain living microorganisms which exert health effects on the host. We compared the efficacy in maintaining remission of the probiotic preparation Escherichia coli Nissle 1917 and established therapy with mesalazine in patients with ulcerative colitis. PATIENTS AND

methodsIn total, 327 patients were recruited and assigned to a double blind, double dummy trial to receive either the probiotic drug 200 mg once daily (n = 162) or mesalazine 500 mg three times daily (n = 165). The study lasted for 12 months and patients were assessed by clinical and endoscopic activity indices (Rachmilewitz) as well as by histology. The primary aim of the study was to confirm equivalent efficacy of the two drugs in the prevention of relapses.

resultsThe per protocol analysis revealed relapses in 40/110 (36.4%) patients in the E coli Nissle 1917 group and 38/112 (33.9%) in the mesalazine group (significant equivalence p = 0.003). Subgroup analyses showed no differences between the treatment groups in terms of duration and localisation of disease or pretrial treatment. Safety profile and tolerability were very good for both groups and were not different.

conclusionsThe probiotic drug E coli Nissle 1917 shows efficacy and safety in maintaining remission equivalent to the gold standard mesalazine in patients with ulcerative colitis. The effectiveness of probiotic treatment further underlines the pathogenetic significance of the enteric flora.

Indexed as

Escherichia coliAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeDouble-Blind MethodFemaleHumansMaleMesalamineMiddle AgedProbioticsRecurrenceRemission InductionAnti-Inflammatory Agents, Non-SteroidalMesalamine

Identifiers

PMID15479682
PMCPMC1774300
OpenAlexW2124334818

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.