Biome Australia Ltd · ASX:BIO
Biome Australia — Technical Presentation (July 2023)
32 slides from Biome Australia's technical presentation, Jul 6, 2023
Slide 1: Results from the Biome Lift Study
6th July 2023 Results from the Biome LiftTM Study ACTIVATEDPROBIOTICS.COM.AU Practitioner-only probiotics
Slide 2: Biome Lift Probiotic
Biome Lift Probiotic ACTIVATEDPROBIOTICS.COM.AU Practitioner-only probiotics PAGE 2
Slide 3: Biome Lift Probiotic
3 Biome Lift™ Probiotic PAGE To support healthy mood balance and enhance Practitioner-only probiotics sleep quality May help reduce cognitive fatigue Clinically trialled formulation Microbac™ technology: 5x more effective delivery Guaranteed potency FORMULATION ACTIVATEDPROBIOTICS.COM.AU Lactobacill
Slide 4: Gut-brain axis
Gut-brain axis The gut-brain axis refers to the bidirectional communication between the gut and the brain. It involves complex interrelationships between many biological systems, including: ● The gastrointestinal system ● The nervous system ● The immune system ● The endocrine system ● The circulator
Slide 5: Previous studies
Previous studies ACTIVATEDPROBIOTICS.COM.AU Practitioner-only probiotics PAGE 5
Slide 6: Results of the first study
Results of the first study First trial examining the effects of the formulation in Biome Lift Probiotic- Marotta A, Sarno E, Casale A Del, Pane M, Mogna L, Amoruso A, et al. Effects of probiotics on cognitive reactivity, mood, and sleep quality. Front Psychiatry. 2019;10(164):1–11. Results from the
Slide 7: Results of the second study
Results of the second study Beck Depression Inventory (BDI) Psychometric test to measure depression Second trial examining the effects of the formulation in Biome Lift Probiotic- C. Kerksick, R. Jäger, et al. Multi-strain probiotic supplementation increases sleep quality, mood and neurotransmitter l
Slide 8: The Biome Lift Study
8 PAGE The Biome Lift Study Practitioner-only probiotics Biome Australia Limited has received the pre-publication results of the Biome LiftTM Probiotic clinical trial taking place at La Trobe University in Melbourne. These findings are the culmination of a strategic research partnership with La Trob
Slide 9: The hypothesis
9 PAGE The hypothesis Practitioner-only probiotics The study hypothesized that the probiotic experimental group would experience a reduction in the severity of depressive symptoms compared to the control group receiving a placebo, and that this would be mediated by beneficial changes in gut microbio
Slide 10: Study aims and outcome measures
PAGE 10 Study aims and outcome measures Practitioner-only probiotics Primary aim: to assess the efficacy of the Biome Lift™ Probiotic compared with a placebo in reducing the severity of depressive symptoms in patients with subthreshold depression. The primary outcome measure: the subjective assessme
Slide 11: Study aims and outcome measures
PAGE 11 Study aims and outcome measures Practitioner-only probiotics The secondary outcome measures are as followed: 1. Subjective and clinical assessment of depression, anxiety, mood and QoL, using the following validated questionnaires: ● Patient Health Questionnaire (PH9; self-report, brief speci
Slide 12: Study design
PAGE 12 Study design The study was a double-blind randomised parallel group clinical trial of probiotic supplementation versus placebo Practitioner-only probiotics in a 1:1 ratio in patients diagnosed with subthreshold depression. The probiotic or placebo supplementation was taken daily for 3-months
Slide 13: Definition of subthreshold depression
PAGE 13 Definition of subthreshold depression Practitioner-only probiotics Interested participants had to meet the diagnosis of subthreshold depression, via a screening interview with the study psychologist, using the Structured Clinical Interview for DSM-5 (SCID 5). Sub-threshold depression is defi
Slide 14: Inclusion criteria
PAGE 14 Inclusion criteria Practitioner-only probiotics Inclusion Criteria Exclusion Criteria ∙ Male and female adults • Suicidal ideation, with or without a specific plan ∙ Aged between 18 and 65 y • Comorbidity with substance use disorders or organic mental disorders ∙ Not in the underweight catego
Slide 15: Study participant flow diagram
Study participant flow diagram Figure 2 presents the CONSORT flow diagram of study participants.
Slide 16: Baseline characteristics
Baseline characteristics Table 2 summarises the descriptive characteristics of study participants, in terms of socio-demographics and anthropometrics, in the total sample (n=39) and by treatment arm. The non-existence of differences in almost all of the examined socio-demographic and anthropometric
Slide 17: Pre-publication results
Pre-publication results ACTIVATEDPROBIOTICS.COM.AU Practitioner-only probiotics PAGE 17
Slide 18: Results summary
PAGE 18 Results summary Results from the self-report questionnaires provide evidence on the effectiveness of the Biome Lift intervention in reducing the severity of Practitioner-only probiotics depressive symptoms in patients with subthreshold depression. According to these findings, although there
Slide 19: Questionnaire results
Questionnaire results Table 5 summarises the within-group changes and between-group differences in the examined depression, mood, anxiety, stress and quality of life scores that were assessed throughout the 12-month intervention period, via the administered self-report questionnaires. The figures on
Slide 20: Questionnaire-Based Assessment Tools
PAGE 20 Questionnaire-Based Assessment Tools BECK DEPRESSION INVENTORY 2nd EDITION Practitioner-only probiotics The Beck Depression Inventory 2nd edition (BDI-II) is designed to assess presence and severity of depressive symptoms. Figure 1: Changes in mean (95% CI) of BDI total scores % improvement
Slide 21: Questionnaire-Based Assessment Tools
PAGE 21 Questionnaire-Based Assessment Tools PATIENT HEALTH QUESTIONNAIRE 9 Practitioner-only probiotics The Patient Health Questionnaire (PH9) is a self-report questionnaire that specifically measures depression. % improvement Figure 2: Changes in mean (95% CI) PHQ total scores ACTIVATEDPROBIOTICS.C
Slide 22: Questionnaire-Based Assessment Tools
PAGE 22 Questionnaire-Based Assessment Tools HADS ANXIETY SUBSCALE (HADS-A) Practitioner-only probiotics The Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression. Figure 3: Changes in mean (95% CI) HADS-A total scores *p < 0.05, significant within-group change from baseline %
Slide 23: Questionnaire-Based Assessment Tools
PAGE 23 Questionnaire-Based Assessment Tools HADS DEPRESSION SUBSCALE (HADS-D) Practitioner-only probiotics % improvement ACTIVATEDPROBIOTICS.COM.AU Figure 4: Changes in mean (95% CI) HADS-D total scores *p < 0.05, significant within-group change from baseline to follow-up. The HADS-D total score dec
Slide 24: Questionnaire-Based Assessment Tools
PAGE 24 Questionnaire-Based Assessment Tools DASS-21 DEPRESSION SUBSCALE (DASS-D) Practitioner-only probiotics % improvement The Depression, Anxiety and Stress Scale (DASS-21) provides separate severity ratings for depression, anxiety ACTIVATEDPROBIOTICS.COM.AU and stress. Figure 5: Changes in mean
Slide 25: Questionnaire-Based Assessment Tools
PAGE 25 Questionnaire-Based Assessment Tools DASS-21 STRESS SUBSCALE (DASS-S) Practitioner-only probiotics ACTIVATEDPROBIOTICS.COM.AU Figure 6: Changes in mean (95% CI) DASS-S total scores *p < 0.05, significant within-group change from baseline to follow-up. The DASS-S total score decreased signific
Slide 26: Anthropometrics data
PAGE 26 Anthropometrics data Table 3 illustrates the changes observed in body weight and body mass index from baseline to the follow-up points (i.e., Practitioner-only probiotics at 6 and 12 weeks), the changes within each treatment arm as well as the differences between them. As per the results in
Slide 27: Dietary intake data
Dietary intake data The within-group changes observed in dietary energy and macronutrients’ intake from baseline to follow-up time points, as well as the between-group differences are summarised in Table 4. A 24-hour food recall diary was used to assess significant changes in diet intake across the
Slide 28: 6 week follow-up
6 week follow-up Table 6 presents the within-group changes and between-group differences in the examined depression, mood, anxiety, stress, and quality of life scores from baseline to the 18-week follow-up time-point (i.e., 6 weeks post-intervention). The results presented in Table 6 indicate that t
Slide 29: Blood analysis
Blood analysis Table 7 presents the within-group changes and between-group differences in fasting plasma glucose, serum insulin, HOMA-IR (i.e. a biomarker of insulin resistance), serum high-sensitivity CRP (i.e., a marker of inflammation) and total glutathione concentrations (i.e., a peptide with an
Slide 30: Saliva analysis
Saliva analysis Table 8 summarizes the within-group changes and between-group differences in saliva cortisol levels (i.e., as stress biomarker) at awakening (S1), 30-minutes post-awakening (S2) and in the evening at 2030 hours (S3), as well as in the Cortisol Awakening Response (CAR), which represen
Slide 31: Faecal analysis
Faecal analysis Figures 10 and 11 graphically present the gut microbiome diversity measures by timepoint (i.e., baseline, 6-week and 12-week follow-up) and treatment arm (i.e., probiotic and placebo) respectively. According to these figures there were no differences or trends observed between timepo
Slide 32: Thank You
Thank You ACTIVATEDPROBIOTICS.COM.AU Practitioner-only probiotics