Evidence map›Paper›PMID 27707789›Full record

Trial reportJournal of Crohn's & colitis2017

A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease.

Jürgen Schölmerich, Klaus Fellermann, Frank W Seibold, Gerhard Rogler, Jost Langhorst, Stefanie Howaldt, Gottfried Novacek, Andreas Munk Petersen, Oliver Bachmann, Harald Matthes and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 4 pooled it
6.3field-weighted citation impact, top 3% 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

50 citing papers in PubMed, 4 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. Trial
  6. Article
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  9. Review
  10. Frontiers in immunology · 2026
    Review
  11. Isolation ofF1000Research · 2026
    Article
  12. Article
  13. Review
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  15. Article
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  17. Review
  18. Review
  19. Vaccination therapy for inflammatory bowel disease.Human vaccines & immunotherapeutics · 2023
    Review
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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

19 authors at 13 institutions in 4 countries.

Jürgen SchölmerichKlinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany.
Klaus FellermannUK-SH Campus Lübeck, Abt. Gastroenterologie, Lübeck, Germany.
Frank W SeiboldSpital Netz Bern Tiefenau, Abt. Gastroenterologie, Bern, Switzerland.
Gerhard RoglerUniversity of Zurich, Division of Gastroenterology and Hepatology, Zurich, Switzerland.
Jost LanghorstKliniken Essen-Mitte, University of Duisburg-Essen, Integrative Gastroenterologie, Essen, Germany.
Stefanie HowaldtHamburgisches Forschungsinstitut für CED, HaFCED GmbH&Co.KG, Hamburg, Germany.
Gottfried NovacekMedizinische Universität Wien, Universitätsklinik für Innere Medizin III, Vienna, Austria.
Andreas Munk PetersenHvidovre University Hospital, Department of Gastroenterology and Department of Clinical Microbiology, Hvidovre, Denmark.
Oliver BachmannMedizinische Hochschule Hannover, Hannover, Germany.
Harald MatthesGemeinschaftskrankenhaus Havelhöhe, Abt. Gastroenterologie, Berlin, Germany.
Norbert HesselbarthÄrztehaus am Klinikum, Schwalmstadt, Germany.
Niels TeichInternistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten Leipzig & Schkeuditz, Leipzig, Germany.
Jan WehkampRobert-Bosch-Krankenhaus, Abt. Innere Medizin I, Stuttgart, Germany.
Jochen KlausUniversitätsklinikum Ulm, Klinik für Innere Medizin I, Ulm, Germany.
Claudia OttUniversity Hospital of Regensburg, Dept. of Internal Medicine I, Regensburg, Germany.
Karin DilgerDr Falk Pharma GmbH, Freiburg, Germany.
Roland GreinwaldDr Falk Pharma GmbH, Freiburg, Germany.
Ralph MuellerDr Falk Pharma GmbH, Freiburg, Germany.
International TRUST-2 Study Group
Dr Falk Pharma (Germany) · DEEngeriedspital · CHForschungsinstitut für Logistik · DEGemeinschaftskrankenhaus Havelhöhe · DEGoethe University Frankfurt · DEHvidovre Hospital · DKKliniken Essen-Mitte · DEMedical University of Vienna · ATMedizinische Hochschule Hannover · DERobert Bosch Hospital · DEUniversity Hospital Regensburg · DEUniversity Hospital Ulm · DEUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsTo investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis [TSO] versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease [CD].

methodsAdults with active CD [n = 252] randomly received six fortnightly doses of 250, 2500, or 7500 TSO/15 ml suspension/day [TSO 250, TSO 2500, TSO 7500], or 15 ml placebo solution/day, in a double-blind fashion, with 4 weeks' follow-up. Primary endpoint was the rate of clinical remission [Crohn's Disease Activity Index [CDAI] < 150] at end of treatment, ie at Week 12 or withdrawal. Secondary endpoints included the course of clinical remission, rate of clinical response, change in CDAI, change in markers of inflammation, mucosal healing, and Physician's Global Assessment.

resultsClinical remission at Week 12 occurred in 38.5%, 35.2%, and 47.2% of TSO 250, TSO 2500, and TSO 7500 patients, respectively, and in 42.9% of placebo recipients. TSO induced a dose-dependent immunological response. There was no response regarding laboratory markers of inflammation. Other secondary efficacy variables also showed no advantage of TSO over placebo for treatment of active CD. Administration of TSO did not result in any serious adverse drug reaction. Review of non-serious suspected adverse drug reactions following TSO did not reveal any safety concerns.

conclusionsAdministration of 250-7500 TSO fortnightly over 12 weeks was safe and showed a dose-dependent immunological response, but no TSO dose showed a clinically relevant effect over placebo for induction of clinical remission or response in mildly-to-moderately active, ileocolonic CD.

Indexed as

AnimalsCrohn DiseaseDose-Response Relationship, ImmunologicDouble-Blind MethodFemaleHumansImmunotherapyMaleOvumRemission InductionTrichurisYoung AdultCrohn’s diseaserandomizedTrichuris suis ova [TSO]

Identifiers

PMID27707789
PMCPMC5881737
OpenAlexW2529035496

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.