title: A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease.
abstract: OBJECTIVE
  To 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].
  
  
  METHODS
  Adults 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.
  
  
  RESULTS
  Clinical 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.
  
  
  CONCLUSIONS
  Administration 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.
authors.affiliation: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Schölmerich
authors.affiliation: UK-SH Campus Lübeck, Abt. Gastroenterologie, Lübeck, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Fellermann
authors.affiliation: Spital Netz Bern Tiefenau, Abt. Gastroenterologie, Bern, Switzerland.
authors.forename: Frank W
authors.initials: FW
authors.lastname: Seibold
authors.affiliation: University of Zurich, Division of Gastroenterology and Hepatology, Zurich, Switzerland.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Rogler
authors.affiliation: Kliniken Essen-Mitte, University of Duisburg-Essen, Integrative Gastroenterologie, Essen, Germany.
authors.forename: Jost
authors.initials: J
authors.lastname: Langhorst
authors.affiliation: Hamburgisches Forschungsinstitut für CED, HaFCED GmbH&Co.KG, Hamburg, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Howaldt
authors.affiliation: Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Vienna, Austria.
authors.forename: Gottfried
authors.initials: G
authors.lastname: Novacek
authors.affiliation: Hvidovre University Hospital, Department of Gastroenterology and Department of Clinical Microbiology, Hvidovre, Denmark.
authors.forename: Andreas Munk
authors.initials: AM
authors.lastname: Petersen
authors.affiliation: Medizinische Hochschule Hannover, Hannover, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Bachmann
authors.affiliation: Gemeinschaftskrankenhaus Havelhöhe, Abt. Gastroenterologie, Berlin, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Matthes
authors.affiliation: Ärztehaus am Klinikum, Schwalmstadt, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hesselbarth
authors.affiliation: Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten Leipzig & Schkeuditz, Leipzig, Germany.
authors.forename: Niels
authors.initials: N
authors.lastname: Teich
authors.affiliation: Robert-Bosch-Krankenhaus, Abt. Innere Medizin I, Stuttgart, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Wehkamp
authors.affiliation: Universitätsklinikum Ulm, Klinik für Innere Medizin I, Ulm, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Klaus
authors.affiliation: University Hospital of Regensburg, Dept. of Internal Medicine I, Regensburg, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Ott
authors.affiliation: Dr Falk Pharma GmbH, Freiburg, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Dilger
authors.affiliation: Dr Falk Pharma GmbH, Freiburg, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Greinwald
authors.affiliation: Dr Falk Pharma GmbH, Freiburg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Mueller
mesh_terms: D000818:Animals; D003424:Crohn Disease / Q000628:therapy*; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D010063:Ovum / Q000276:immunology*; D012074:Remission Induction / Q000379:methods; D014258:Trichuris / Q000276:immunology*; D055815:Young Adult
keywords: Crohn’s disease; Trichuris suis ova [TSO]; randomized