Background – A double-blind randomised controlled trial in 2010 on diarrhoea caused by Escherichia coli (E. coli) in piglets, has shown promise in significantly fewer piglets becoming ill with diarrhoea in the homeopathy group compared with placebo.
Aim – Our objective is to present the study protocol of a clinical trial (ETEC-HOM) that will assess the efficacy and safety of the HOMeopathic medicinal product E. coli C30 in EnTerotoxigenic E. Coli diarrhoea in piglets during the first 2 weeks after weaning.
Methods – A prospective, cluster-randomised, placebo-controlled, double-blind, two-arm monocentre study has been designed. Sows without post-partum dysgalactia syndrome will be included in the trial. The decision regarding the suitability of the sows and their piglets for inclusion in the study will be in line with defined criteria according to Baumgartner & Wittek 2016 and Hirsch et al. 2003. The medical intervention includes sows and their piglets being randomly assigned to one of two prophylaxis and treatment arms: verum or placebo. The prophylaxis and treatment will consist of E. coli C30 or indistinguishable placebos. Both groups will be treated with conventional medicine if indicated. The primary outcomes are the evaluation of the incidence of ETEC diarrhoea in piglets, confirmed by cultivation of ETEC, and of the antibiotic treatment days needed for treatment of ETEC diarrhoea in piglets per animal days at risk during the first 2 weeks after weaning. Secondary outcomes are performance parameters such as daily weight gain and mortality. Adverse events will be documented.
Discussion – The ETEC-HOM trial protocol is designed to investigate a homeopathic strategy for treatment of ETEC diarrhoea in weaned piglets. Favourable outcomes for homeopathy could prompt subsequent studies and meta-analysis.