Нова људска студија о ефектима живих биотерапеутика на несаницу

А ХОЛД ФрееРелеасе 6 | eTurboNews | еТН

Servatus Ltd. announced it 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.”

She continued, “To date, the role of the microbiome in sleep health has been under-recognised and under-researched. However, there is a link between the gut microbiome and sleep through modulating inflammation, regulating neurotransmitter synthesis and organising human circadian rhythm. That is why influencing the microbiome to a healthier composition could offer a promising new treatment option for insomnia.”

Dr Wayne Finlayson, Servatus’ CEO commented: “We are excited to begin recruitment for this important trial. It is a first for Australia and we hope it will enable better health outcomes for people suffering from insomnia. With an improved understanding of the microbiome-gut-brain axis and how the interaction between these organs may affect sleep, Servatus is hoping to deliver a new treatment for insomnia.”

Insomnia Overview

Insomnia is a multi-faceted sleep disorder impeding both physical and mental performance. Cumulative effects of long-term sleep loss can result in adverse health outcomes, affecting neuroendocrine, metabolic and immune processes. These affects are often accompanied or preceded by other medical or psychiatric conditions such as diabetes, hypertension, heart disease, depression, substance abuse and Alzheimer’s disease.

According to the Sleep Health Foundation August 2021, more than half (59.4%) of the Australian population suffers from at least one chronic sleep symptom. 14.8% had chronic insomnia when classified by the International Classification of Sleep Disorders (Version. 3 Criteria).

The combined direct and indirect costs of sleep disorders to the Australian economy and society is $51 billion per annum. New analysis published in the Journal of Clinical Sleep Medicine 2021, estimated 13.6 million had at least one Sleep Disorder in the United States, equating to a conservative estimate of $94.9 billion in healthcare costs per annum.

Trial Recruitment

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

О аутору

Аватар Линде Хохнхолц

Линда Хохнхолз

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