Servatus Ltd, an Australian biopharmaceutical company delivering leading novel autoimmune and microbiome therapies, has begun recruitment for its Phase I/II clinical trial for insomnia at the Sleep Disorders Centre at The Prince Charles Hospital in Queensland. This is the first study to research the effects of live biotherapeutics on patients with clinically diagnosed insomnia in Australia.

The study will examine the safety and efficacy of the treatment across 50 patients over a 35 Day treatment period, with the aim to assess the effect the live biotherapeutic has on gut microbiome composition and function and its association with healthy sleep patterns.

Dr Deanne Curtin, Sleep Disorders Centre Director at the Prince Charles Hospital said, "There is a definable gap in the development of safe and effective long-term solutions for insomnia. Improving sleep habits and behaviour therapy are typically the first approach in managing insomnia but most people do not seek professional support and may turn to over-the-counter medications to self-medicate. However, current medications, whether prescribed or over-the-counter are for short-term use only, may have undesirable side effects and do not treat the underlying cause."

The Servatus trial will run during 2022, with final results expected in 2023.

Image caption- Robert Skelton, Labor MP; Wayne Finlayson, CEO, Servatus; Cameron Dick, treasurer for Queensland.