Schoelmerich, Juergen and Fellermann, Klaus and Seibold, Frank W. and Rogler, Gerhard and Langhorst, Jost and Howaldt, Stefanie and Novacek, Gottfried and Petersen, Andreas Munk and Bachmann, Oliver and Matthes, Harald and Hesselbarth, Norbert and Teich, Niels and Wehkamp, Jan and Klaus, Jochen and Ott, Claudia and Dilger, Karin and Greinwald, Roland and Mueller, Ralph (2017) A Randomised, Double-blind, Placebo-controlled Trial of Trichuris suis ova in Active Crohn's Disease. JOURNAL OF CROHNS & COLITIS, 11 (4). pp. 390-399. ISSN 1873-9946, 1876-4479
Full text not available from this repository. (Request a copy)Abstract
Background and 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 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | INFLAMMATORY BOWEL DISEASES; HELIGMOSOMOIDES-POLYGYRUS; ULCERATIVE-COLITIS; ACTIVITY INDEX; IMMUNE-SYSTEM; INFECTION; AUTOIMMUNE; THERAPY; HYGIENE; PARASITES; Crohn's disease; randomized; Trichuris suis ova [TSO] |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2018 13:11 |
| Last Modified: | 20 Feb 2019 14:59 |
| URI: | https://pred.uni-regensburg.de/id/eprint/1143 |
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