Preliminary analysis of a phase IIa trial using Medlab Clinical’s (ASX: MDC) probiotic NRGBiotic has revealed a “significant” reduction in depression.
The trial involved administering NRGBiotic to patients diagnosed with major depression. The probiotic was given in combination with a patient’s anti-depressant prescription which was either a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor.
NRGBiotic contains several probiotic species of lactobacillus acidophilus, bifidobacterium bifidum and streptococcus thermophilus along with orotic acid.
The trial was completed at the end of March last year with 120 out of 150 patients treated.
Queensland’s University of Technology undertook independent pathology covering multiple time points along with the QIMR Berghofer Medical Research Institute.
However, COVID-19 restrictions resulted in processing delays.
Medlab director of medical research Prof Luis Vitetta said preliminary analysis of the phase IIa study showed a “significant” reduction in depression scores from a baseline 30.9 (severe range) through to week eight which averaged 15.93, which was described as being in the mild range.
He added this was a “statistically significant” preliminary result.
“The other standout points were the confirmed safety and tolerability factor for the NRGBiotic administered cohort that presented with no adverse effects from the probiotic formulation,” Prof Vitetta said.
Gut bacteria and depression
More than 264 million people are believed to suffer from depression worldwide. It is also a leading cause of disability.
The gut microbiome of patients diagnosed with major depression correlated to a decreased abundance in gut bacterial phyla firmicutes and proteobacteria, which Medlab says confirms results from previous studies.
During the trial, it was observed that there is was also a strong positive association of depression severity with increased abundance from the bacterial genus paraprevotella.
Medlab’s study showed the administration of NRGBiotic increased faecal abundance of bifidobacterium bifidum from baseline to eight weeks.
There was also a “significant” increase in abundance in the immune regulating/enhancing bacterial genus bifidobacterial in the treatment group. This genus has been reportedly associated with anti-inflammatory/pro-inflammatory regulating properties in the intestines.
Ongoing development of NRGBiotic
NRGBiotic is a multi-patented probiotic that is available in Australian pharmacies.
Medlab chief executive officer Dr Sean Hall said NRGBiotic was a “very unique formulation” based on years of hard work.
“The encouraging preliminary results of the depression study affirm our belief that NRGBiotic, used as an adjunct, can be of great help to people who suffer from depression, and whose current medication regime may not be producing a desired outcome,” he explained.
“Depression is a global epidemic, affecting just over 5% of the world’s population.”
Dr Hall said health authorities expected the rate of depression to rise with current medication strategies only working with about two-thirds of patients.
“I look forward to the ongoing development of this program, and the real-world opportunities NRGBiotic offers,” Dr Hall added.