RecruitingPhase 2ACTRN12621001413819

Assessing a live microbial therapy for the treatment of Insomnia

A Phase I/II Randomised, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of a Live Biotherapeutic Product (SVT-4A1011) in Adults with Clinically Diagnosed Insomnia

Sponsor

Servatus Ltd

Enrollment

50 participants

Start Date

Mar 28, 2022

Study Type

Interventional

Conditions

Insomnia

Summary

The aim of this study is to evaluate safety and tolerability of SVT-4A1011 as a treatment for Insomnia together with preliminary efficacy. The treatment consists of selected bacterial species that are naturally found in the digestive tract. They are a research focus for their important role in many conditions related to gut health. Bacteria play an important role in the function of the immune system, digestive health, inflammation and gut/brain axis. Several research studies have identified certain gut bacteria having direct interaction and regulation of key neurotransmitters and pathways associated with sleep including influencing the host circadian rhythm. This study will help determine how safe and effective SVT-4A1011 is as a stand-alone therapy in treating Clinically Diagnosed Insomnia. The hypothesis of this study is that, twice daily consumption of the study drug SVT-4A1011 will result in improved quality of sleep in individuals with clinically diagnosed insomnia.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a live bacterial therapy — containing naturally occurring gut bacteria — can safely improve sleep quality in people with clinically diagnosed insomnia. The gut-brain connection is an exciting area of research, and scientists have found that certain gut bacteria can influence brain chemicals and the body's natural sleep-wake cycle. This trial tests whether taking SVT-4A1011 twice daily can improve sleep in people who struggle with insomnia. Insomnia is extremely common and can seriously affect quality of life, mental health, and physical wellbeing. Current treatments like sleeping tablets can have side effects and dependency risks. A probiotic-based approach could offer a gentler, more natural alternative if proven effective. Participants in this Phase 2 trial will take the study product or a placebo for a set period and have their sleep tracked and assessed. You may be eligible if you are between 18 and 70 years old, have been clinically diagnosed with insomnia with an Insomnia Severity Index score of 8 or above, have experienced poor sleep at least three nights per week for more than three months, and do not have untreated sleep apnoea, a major psychiatric disorder, or a compromised immune system.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The overall study duration consists of a total of 7 weeks consisting of 2 weeks of screening/baseline assessment and 5 weeks of intervention (treatment). Participants will be provided with 3 bottles of either the investigational medicine (SVT-4A1011) or Placebo at Baseline (Day 0) as an oral liquid. Participants will consume 10 mL of SVT-4A1011 or Placebo twice daily, morning and evenings for 35 Days on an empty stomach. Participants will record their adherence to the intervention in a participant diary, along with any adverse events and any concomitant medications taken during the study period. At the end of 35 Days participants will return to the clinic for assessment.