Background

This area was of specific interest to Medlab, and embarked on rigorous studies in efforts to understand the gut/brain axis and diminish or halt the uremic toxins produced by the gut and understand its therapeutic translation to human health.

The goal was to produce a first-in-class probiotic that positively influences the gastrointestinal environment, and the production of uremic toxins, and diminished the pro-cytokine “storm” associated with mental health issues and potentially auto-immune function.

Multiple studies were undertaken to get to the final formulation Medlab marketed as a nutraceutical (ARTG listed medicine), NRGBiotic™.

NRGBiotic™, as a nutraceutical was used in the collaborative Phase 2a study with the Queensland University of Technology.

The Product - NRGBIOTIC™

The successful research undertaken provided for a first-in-class probiotic for the treatment of major depressive disorder, and subsequent patents in global territories, see here.

The formulation was entered into the ARTG as a listed medicine as NRGBiotic™, see here. Medlab’s goal (although unrealised, was to synthesize NRGBiotic™ compounds for formal drug approval). As a listed medicine (aka as a nutraceutical) claims with the Australian TGA included:

• Supports healthy mood balance and reduces symptom occurrence of mild anxiety

• Aids the synthesis of neurotransmitters and supports nervous system health

• Helps balance the gut-brain axis

• Enhances energy levels

• Promotes healthy muscle function, improves exercise performance and post-exercise recovery.

The product is described as an orotate with 3 specific probiotic strains in exact ratios.

The Phase 2a Study - ethics approved and published

Simply known as the “Depression” study; originally proposed for 150 participants, but due to COVID-19 closed at 120.

The study was a randomised, double-blind, placebo-controlled study by Drs Bambling and Strodl from the Queensland University of Technology.

Studies arms included an SSRI arm (the control group) and an NRGBiotic™ as an adjuvant to an SSRI arm (the experimental group).

All participants were diagnosed with major depressive disorders.

The Results

The Primary Outcomes (2/2 MET) were:

1. MET – Participants taking both NRGBiotic™, and an anti-depressant had greater symptom

   remission over the 8 weeks period than those on an anti-depressant alone (p=0.015).

2. MET - Incidence of dysbiosis assessed by faecal analysis showed both groups were dysbiotic,

   holding to the premise that anti-depressant medications adversely affect the intestinal bacteria

   leading to an unbalanced dysbiotic gut.

The Secondary Outcomes (2/3 MET) were:

1. MET - Participants taking both NRGBiotic™ and an anti-depressant had greater proportional

   increase in Quality of Life (QoL) Scale from baseline to 8 weeks, than those on anti-depressants

   alone (p=0.015).

2. MET - Participants taking both NRGBiotic™ and an anti-depressant had greater improvement in

   non-clinical levels of symptoms (e.g., interpersonal, social, etc) than those on anti-depressant

   medications alone (p=0.003)

3. NOT MET - The proportion of participants with a reduction in lipopolysaccharides (LPS^) showed no noticeable differences between the groups.

The results are significant supporting Medlab’s proprietary patented product NRGBiotic™ is a vital adjunctive therapy to antidepressant medications - Research shows approximately 33% of patients prescribed an antidepressant medication are non-responders. Medlab conducted this study with Major Depressive Disorder patients, with 33 also being non-responder patients, our results highlight that using NRGBiotic™ with an antidepressant produced significantly better outcomes than taking antidepressant medications with a placebo.