Anatara Lifesciences provided an update on progress of clinical trials in psychological functioning and irritable bowel syndrome, diarrhoea subtype (IBS-D). Following successful
completion of the site initiation visit, recruitment will commence on 21 February 2022. The final study report is anticipated in late 2022. "This CSIRO site has also been initiated for the GaRP trial in IBS-D and recruitment has commenced. The interim report is anticipated in August 2022 and the final report in January 2023. Anatara's 3FDC is several of the components of the GaRP (Gastrointestinal reprogramming) complementary medicine. The 3FDC components are coated for targeted release predominately beyond the small intestine to allow delivery and influence in the large intestine. The 3FDC components are anticipated to have direct and indirect effects including assisting the homeostasis of a healthy microbiome. The delivery of these components and the microbiome influences are considered important for gut-brain axis balance, hence the 3FDC components have been selected to explore their effect on depression, anxiety and stress symptoms in otherwise healthy individuals. This randomised, double-blinded, placebo-controlled study into the effects of 3FDC in adults with moderate anxiety, stress or depression will be conducted at CSIRO's Nutrition and Health Research Clinic in Adelaide. Approximately 100 participants will be randomised in a 1:1 manner for treatment with 3FDC or a placebo, dosed twice a day for 6 weeks. Anatara's 3FDC components have been selected to explore their effect on mood, anxiety and stress in otherwise healthy individuals as the delivery of these components to the large intestine is considered likely to have beneficial effects on the gut-brain axis including positively influencing the homeostasis of the microbiome . Mood/relaxing supplements were 1,3 billion EUR in 2019 (Euromonitor's Health and Nutrition Survey Jan & Feb. 2020).1 About 19% U.S. adults have an anxiety disorder in any given year, and an estimated 31% have an anxiety disorder at some time in their lives, and depression is a medical condition that affects about 1 in 10 U.S. adults.2 An estimated 38.2% of the population of the EU member states (approximately 165 million people; 2010) met the criteria for a psychiatric disorder, while fewer than one-third received treatment for it (Wittchen et al., 2011).3 24% of U.S. adults with a mental illness report an unmet need for treatment. 40% or more of Americans treat themselves with CAM without professional supervision, often without disclosing it to their psychiatrist or primary care provider. People considering using CAM treatments need to make an informed decision, just as they would with any synthetic medication or other treatment, weighing the evidence about effectiveness, drug interactions, side effects, and less dangerous options, to come up with a risk/benefit assessment.