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A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease

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Harvard

Schölmerich, J, Fellermann, K, Seibold, FW, Rogler, G, Langhorst, J, Howaldt, S, Novacek, G, Petersen, AM, Bachmann, O, Matthes, H, Hesselbarth, N, Teich, N, Wehkamp, J, Klaus, J, Ott, C, Dilger, K, Greinwald, R, Mueller, R & International TRUST-2 Study Group 2017, 'A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease', Journal of Crohn's & colitis, bind 11, nr. 4, s. 390-399. https://doi.org/10.1093/ecco-jcc/jjw184

APA

Schölmerich, J., Fellermann, K., Seibold, F. W., Rogler, G., Langhorst, J., Howaldt, S., Novacek, G., Petersen, A. M., Bachmann, O., Matthes, H., Hesselbarth, N., Teich, N., Wehkamp, J., Klaus, J., Ott, C., Dilger, K., Greinwald, R., Mueller, R., & International TRUST-2 Study Group (2017). A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease. Journal of Crohn's & colitis, 11(4), 390-399. https://doi.org/10.1093/ecco-jcc/jjw184

CBE

Schölmerich J, Fellermann K, Seibold FW, Rogler G, Langhorst J, Howaldt S, Novacek G, Petersen AM, Bachmann O, Matthes H, Hesselbarth N, Teich N, Wehkamp J, Klaus J, Ott C, Dilger K, Greinwald R, Mueller R, International TRUST-2 Study Group. 2017. A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease. Journal of Crohn's & colitis. 11(4):390-399. https://doi.org/10.1093/ecco-jcc/jjw184

MLA

Vancouver

Author

Schölmerich, Jürgen ; Fellermann, Klaus ; Seibold, Frank W ; Rogler, Gerhard ; Langhorst, Jost ; Howaldt, Stefanie ; Novacek, Gottfried ; Petersen, Andreas Munk ; Bachmann, Oliver ; Matthes, Harald ; Hesselbarth, Norbert ; Teich, Niels ; Wehkamp, Jan ; Klaus, Jochen ; Ott, Claudia ; Dilger, Karin ; Greinwald, Roland ; Mueller, Ralph ; International TRUST-2 Study Group. / A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease. I: Journal of Crohn's & colitis. 2017 ; Bind 11, Nr. 4. s. 390-399.

Bibtex

@article{6fe4da0c3a45457c96f1162cab47d494,
title = "A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease",
abstract = "BACKGROUND & AIMS: 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 15ml placebo solution/day, in a double-blind fashion, with four weeks' follow-up. Primary endpoint was the rate of clinical remission (Crohn's disease activity index [CDAI]<150) at end of treatment, i.e. 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.CONCLUSION: 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.",
author = "J{\"u}rgen Sch{\"o}lmerich and Klaus Fellermann and Seibold, {Frank W} and Gerhard Rogler and Jost Langhorst and Stefanie Howaldt and Gottfried Novacek and Petersen, {Andreas Munk} and Oliver Bachmann and Harald Matthes and Norbert Hesselbarth and Niels Teich and Jan Wehkamp and Jochen Klaus and Claudia Ott and Karin Dilger and Roland Greinwald and Ralph Mueller and {International TRUST-2 Study Group}",
note = "{\textcopyright} European Crohn{\textquoteright}s and Colitis Organistion (ECCO) 2016.",
year = "2017",
month = apr,
doi = "10.1093/ecco-jcc/jjw184",
language = "English",
volume = "11",
pages = "390--399",
journal = "Journal of Crohn's and Colitis",
issn = "1873-9946",
publisher = "Elsevier BV",
number = "4",

}

RIS

TY - JOUR

T1 - A randomised, double-blind, placebo-controlled trial of Trichuris suis ova (TSO) in active Crohn's disease

AU - Schölmerich, Jürgen

AU - Fellermann, Klaus

AU - Seibold, Frank W

AU - Rogler, Gerhard

AU - Langhorst, Jost

AU - Howaldt, Stefanie

AU - Novacek, Gottfried

AU - Petersen, Andreas Munk

AU - Bachmann, Oliver

AU - Matthes, Harald

AU - Hesselbarth, Norbert

AU - Teich, Niels

AU - Wehkamp, Jan

AU - Klaus, Jochen

AU - Ott, Claudia

AU - Dilger, Karin

AU - Greinwald, Roland

AU - Mueller, Ralph

AU - International TRUST-2 Study Group

N1 - © European Crohn’s and Colitis Organistion (ECCO) 2016.

PY - 2017/4

Y1 - 2017/4

N2 - BACKGROUND & AIMS: 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 15ml placebo solution/day, in a double-blind fashion, with four weeks' follow-up. Primary endpoint was the rate of clinical remission (Crohn's disease activity index [CDAI]<150) at end of treatment, i.e. 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.CONCLUSION: 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.

AB - BACKGROUND & AIMS: 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 15ml placebo solution/day, in a double-blind fashion, with four weeks' follow-up. Primary endpoint was the rate of clinical remission (Crohn's disease activity index [CDAI]<150) at end of treatment, i.e. 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.CONCLUSION: 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.

U2 - 10.1093/ecco-jcc/jjw184

DO - 10.1093/ecco-jcc/jjw184

M3 - Journal article

C2 - 27707789

VL - 11

SP - 390

EP - 399

JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

SN - 1873-9946

IS - 4

ER -

ID: 49085616