Gut-Brain Axis and Omni-Biotic Stress Release Publications

Diagram illustrating the gut-brain axis, showing connections between the gut microbiota, vagus nerve, and brain regions involved in stress and emotions

A complex, bidirectional communications network exists between the gut and the central nervous system which includes the brain, spinal cord, hormonal pathways and the gut associated lymphoid tissue (the gut’s immune system or GALT). Imbalances in the gut can result in toxin leakage, inflammation, and related mood and cognition symptoms including brain fog, anxiety, and stress.

Clinical studies have demonstrated the psychobiotic power of OMNi-BiOTiC® Stress Release with outcomes including improved mood, decision making, cognitive understanding, and memory.

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Human Clinical Trials on Final Formulation

The following studies were performed on the commercial Omni-Biotic formulation available in the US market. In some cases the brand name will differ based on the European marketed product, but probiotic strains and formulation are identical.

The PROVIT Study-Effects of Multi-species Probiotic Add-on Treatment on Metabolomics in Major Depressive Disorder-A Randomized, Placebo-Controlled Trial.
Author/Year: Kreuzer et al; 2022
Study Type: Randomized Controlled Trial (RCT)
Key findings include:
Shift toward significantly higher levels of:
  • Butyrate
  • Alanine
  • Valine
  • Isoleucine
  • Sarcosine
  • Methylamine
  • Lysine
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Effects of Probiotic Strains on Disease Activity and Enteric Permeability in Psoriatic Arthritis–A Pilot Open-Label Study
Author/Year: Haidmayer et al., 2020
Study Type: Pilot Study
Key findings include:
  • Reduction in psoriatic arthritis disease activity
  • Reduced in fecal zonulin (marker of intestinal permeability)
  • Reduced fecal calprotectin (marker of intestinal inflammation)
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"Influence of 4-week multi-strain probiotic administration on resting state functional connectivity in healthy volunteers"
Author/Year: Bagga, et al.; 2019
Study Type: Randomized Controlled Trial (RCT)
Key findings include:
  • Decreased functional connectivity in default mode, middle and superior frontal gyrus networks
  • Increased functional connectivity in salience network (cingulate gyrus and precuneus cortex)
  • Brain activity shift indicative of less connectivity associated with ruminative thought and more connectivity associated with executive function
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The Impact of Probiotic Supplements on Cognitive Parameters in Euthymic Individuals with Bipolar Disorder: A Pilot Study.
Author/Year: Reininghaus et al; 2018
Study Type: Pilot Study
Key findings include:
Significant improvements in:
  • Attention
  • Psychomotor processing speed
  • Executive function
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Probiotics drive gut microbiome triggering emotional brain signatures
Author/Year: Bagga, et al.; 2018
Study Type: Randomized Controlled Trial (RCT)
Key findings include:
  • Improved positive affect and cognitive reactivity
  • Improved memory performance
  • Improved gut microbiome diversity
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Effects of an oral symbiotic on the gastrointestinal immune system and microbiota in patients with diarrhea-predominant irritable bowel syndrome
Author/Year: Moser et al., 2018
Study Type: Observational Study
Key findings include:
  • 80% reduction in IBS symptom severity
  • 46% reduction in zonulin (leaky gut marker)
  • Anti-inflammatory effects in the colon
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Probiotic Supplementation in Patients with Alzheimer’s Dementia - An Explorative Intervention Study
Author/Year: Leblhuber et al., 2018
Study Type: Observational Study
Key findings include:
  • Significant improvement in zonulin levels (gut barrier integrity)
  • Increase in the anti-inflammatory Faecalibacterium prausnitzii
  • Increased levels of neuroprotective kynurenine
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Reviews

The following papers are not specific to Omni-Biotic products but are provided here for informational and educational purposes.

The gut-brain axis: interactions between enteric microbiota, central and enteric nervous systems
Year Published: 2015
Study Type: Review

This review summarizes the available evidence describing the bi-directional gut-brain relationship including neural, endocrine, immune, and humoral pathways. It also explores relevant pathophysiological mechanisms.
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Stress and the Microbiota–Gut–Brain Axis in Visceral Pain: Relevance to Irritable Bowel Syndrome
Year Published: 2015
Study Type: Review

This review highlights the evidence supporting the connection between stress and the gut microbiota, with specific focus on the mechanisms by which the microbiota impacts stress response, behavior, and visceral pain.
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