A Randomised, Double-blind, Placebo-controlled Trial ofTrichuris suisova in Active Crohn’s disease

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.

Safety of P28GST, a Protein Derived from a Schistosome Helminth Parasite, in Patients with Crohn’s Disease: A Pilot Study (ACROHNEM)

“…Pioneering clinical trials showed that treatments of helminth eggs or larvae provided some clinical improvement in patients with CD and ulcerative colitis with no AEs [4,14,15]. However, a recent phase 2, randomized, placebo-controlled, multicenter trial that tested Trichuris suis ova (TSO) in patients with active CD showed that TSO efficacy was not significantly superior to placebo [16]. In addition to testing helminths as an alternative therapy for intestinal diseases, helminth-derived anti-inflammatory mediators have been identified.…”

Worms: Pernicious parasites or allies against allergies?

“…These initial studies formed the basis of clinical trials treating patients with IBD or multiple sclerosis in the United States and Europe with TSO. However, to date, these trials have shown disappointing response rates and no significant reduction compared with placebo controls …”

“…Image is adapted from Servier Medical ART response rates and no significant reduction compared with placebo controls. [83][84][85] Of most relevance to this review, studies using hookworm infection to treat asthma or TSO to treat allergic rhinitis patients have also been undertaken. However, no change in clinical measurements was seen in either study, 86 and although type 2 specific responses were detected against the hookworm, no regulatory immune responses were found.…”

Komplementäre Therapieverfahren in der aktualisierten AWMF-S3-Leitlinie «Diagnostik und Therapie der Colitis ulcerosa»: Der Stellenwert von Therapieansätzen aus dem komplementären Bereich nimmt weiter zu

“…bei den Eiern des Schweinepeitschenbandwurms ( Trichuris suis ovata ). Im Jahr 2011 noch als vielversprechende Therapiemöglichkeit aufgeführt, wurde diese Option nun aufgrund von 2 negativ ausgefallenen großen randomisiert-kontrollierten Studien - 1 aus Europa und 1 aus Nordamerika - zur Remissionsinduktion bei Morbus Crohn verworfen und wird als mögliche Therapie bei chronisch-entzündlichen Darmerkrankungen - und somit auch Colitis ulcerosa - generell nicht weiter verfolgt [6]. …”