Atlantia is a world-class provider of human clinical studies. For over a decade we have delivered clinical results to our many clients around the world, on time and on budget. We strive to offer the highest quality science while maintaining a cost-conscious approach to maximize the value proposition for each of our clients.
Sleep Quality & Immunity: A Probiotic Human Clinical Study Unlocking the Science of Sound Sleep: Discover How Probiotics Redefined Sleep Quality and Immunity in our Groundbreaking Clinical Trial.
In this case study, we will explore how Atlantia, a leading Microbiome Contract Re- search Organisation (CRO), partnered with a prominent sponsor to design and conduct a groundbreaking human clinical trial. The objective of the trial was to investigate the effects of probiotic supplementation on sleep quality and its implications on immunity. This study addresses the growing need for effective and safe treatments for disturbed sleep, considering its significant impact on cognitive impairment, affective disruption, and physical disease.
CLIENT BACKGROUND The sponsor, a renowned supplement manufacturer, recognised the importance of addressing sleep-related issues and their impact on overall health. They sought a trusted partner with the expertise and capabilities to conduct a gold-standard clinical trial to explore the potential bene- fits of probiotics on sleep quality and relevant biomarkers.
HOW ATLANTIA’S SOLUTION HELPED
Atlantia’s world-class team, consisting of doctors, scientists, nutritionists, and research nurses, collaborated closely with the sponsor’s researchers to craft a comprehensive study design. The team’s expertise in sleep, stress, and cognition was instrumental in tailoring the study to meet the sponsor’s specific research needs. Leveraging their proficiency in objective and subjective sleep assessments, Atlantia was well-equipped to lead this project.
To investigate the efficacy of probiotic sup- plementation in improving sleep quality in a general population
To determine whether immune, metabolic, and stress-related biomarkers exhibited signifi- cant differences in individuals with poor sleep quality.
IMPLEMENTATION The study followed a randomized, double-blind, place- bo-controlled, parallel-group design, adhering to the high- est research standards.
Over an 8-week intervention period, otherwise healthy sub- jects with specific sleep-related indexes were recruited to participate in the trial.
Subjects were carefully selected through a multi-faceted re- cruitment process, including database screening, outreach to General Practitioners’ offices, social media platforms, and local newspaper adverts.
Online questionnaires helped determine subject eligibility: • Pittsburgh Sleep Quality Index (PSQI) • Hospital Anxiety and Depression Scale (HADS) • Short Form 36 (SF36)
• Insomnia Sleep Index (ISI) • Perceived Stress Scale (PSS)
Eligible subjects then attended an on-site screening visit.
The trial yielded promising results. Objective sleep quality, including sleep latency, efficiency, and wake episodes, showed significant improvements in the group receiving probiotic supple- mentation compared to the placebo group. Moreover, self-reported physical and mental health, alongside blood biomarkers (inflammatory, hormonal, tryptophan, and metabolic markers), ex- hibited noteworthy positive changes in the probiotic intervention group.
BENEFITS AND IMPACT
The study demonstrated the potential of probiotics as a safe and effective means to improve sleep quality in the general population. These findings hold significant implications for individ- uals seeking solutions for sleep-related issues and contribute to the growing body of research on probiotic interventions.
Atlantia’s expertise in designing and conducting this clinical trial, combined with their dedicated team’s commitment, played a vital role in the successful realization of the study’s objectives. The collaboration between Atlantia and the sponsor exemplifies the power of a trusted CRO partnership in advancing scientific knowledge and addressing public health priorities. If your organization is seeking a reliable partner for conducting groundbreaking clinical trials or researching health-related interventions, contact Atlan- tia today. Our expert team is ready to support your research needs and contribute to the advancement of medical knowledge and patient well-being.
Your journey to successful clinical development starts here! Contact us now to advance your re- search objectives and make a positive impact on human health and well-being.
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