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Clasado has published human clinical trials on the prebiotic Bimuno® since 2008.

Research on how the gut microbiome can be modulated through exogenous strains of bacteria (probiotics) has been well documented. The effects of stimulating endogenous bacteria through consumption of dose-controlled prebiotics are arguably less well known.

The research journey started at the University of Reading by demonstrating how beneficial endogenous bacteria can be selectively grown in the colon by a unique galactooligosaccharide (GOS) contained in Bimuno, in a replicable way.

Bimuno (also referred to as B-GOS®) is shown to beneficially affect the human gut microbiome through its selective stimulation of bifidobacteria. The proliferation of good bacteria in the gut has been repeatedly demonstrated in studies in healthy adult populations (Depeint, 2008; Vulevic, 2008 & 2015), IBS cohort (Silk, 2009) and obese adults (Vulevic, 2013).

Human research demonstrated the effect of bifidobacteria and associated metabolites on the gut microbiome and the resulting influence on digestive health, immune function and cognitive health.

Digestive discomfort

Bloating, Constipation, Flatulence, Abdominal Pain

Bimuno has been shown to reduce the physical effects of digestive discomfort (Silk, 2009, Vulevic, 2018 and Huaman, 2018). People who have this condition are often advised by nutrition professionals to temporarily avoid fermentable (FODMAP) foods and these foods are largely prebiotic. However not all prebiotics are the same and interestingly although the broad definition of FODMAPs should technically include galactooligosaccharides, Bimuno has been shown to have a comparable symptom lowering effect as low-FODMAP (LF) diets, whilst increasing the levels of bifidobacteria, in contrast to the group on a LF diet (Huaman, 2018).

The gut microbiome has an adaptive response to Bimuno. Flatulence initially increased after supplementation but declined back to baseline levels by day 10 (Mego, 2017).

Immune function

Benefits to the immune system from the modulation of the gut microbiome by Bimuno have also been demonstrated. Improvements in immunity have been measured in terms of an increase in natural killer cells (NK) activity (Vulevic, 2008), an increase in anti-inflammatory cytokines interleukin-10 (IL-10) and interleukin 8 (IL-8) and a decrease in pro-inflammatory cytokine interleukin-1β  (IL-1β) (Vulevic, 2015). In addition, a study on a population with a phenotype of asthma, Exercise-Induced Bronchoconstriction (EIB), found that in improving respiratory function, Bimuno supplementation reduced systemic concentrations of TH2 driven inflammatory markers (Williams, 2016).

A study on overweight adults found that supplementation of Bimuno significantly lowered levels of a general marker of inflammation, plasma C-reactive protein (CRP), and calprotectin which is a specific marker of intestinal inflammation. The same study also found an increase in faecal secretory slgA, which is involved in mucosal immunity and gut barrier function (Vulevic, 2013). This supports the role of Bimuno in beneficially modulating the immune system.

Behaviour, mood and cognition

Modulation of the gut microbiome has also been demonstrated to affect brain function. The modulation of the gut microbiome and the resulting effects on behaviour, mood and cognition (known as the gut microbiome – brain – axis) is a new discipline. Research has shown that Bimuno supplementation can reduce cortisol, a stress hormone, in healthy people and decrease response to negative stimuli (Schmidt, 2015). In a study on autistic children, there were significant improvements in the gut microbiome profile and a decrease in anti-social behaviour when Bimuno was administered (Grimaldi, 2018). There is also extensive supporting evidence for the role of Bimuno in the gut microbiome - brain - axis coming from animal studies.

Travellers' Diarrhoea

Bimuno has been shown to reduce the incidence and duration of travellers' diarrhoea (TD) (Drakouloarakou, 2007; Hasle 2017). These studies were conducted using travellers to countries with medium to high risk of developing TD. Further animal studies have detailed the anti-adhesive effects of Bimuno on pathogenic activity.

Summary of Science

The below show a full reference of the human, animal and in vitro research undertaken on Bimuno.

Digestive Discomfort and Use in Low-FODMAP Diets

  • Effects of Prebiotics vs a Diet Low in FODMAPs in Patients with Functional Gut Disorders (Huaman et al, 2018)
  • Effect of a prebiotic galactooligosaccharide mixture (B-GOS®) on gastrointestinal symptoms in adults selected from a general population who suffer from bloating, abdominal pain, or flatulence (Vulevic et al, 2018)
  • Clinical trial: the effects of a trans-galactooligosaccharide prebiotic on faecal microbiota and symptoms in irritable bowel syndrome (Silk et al, 2009)

    • Cognitive Function

  • Increased cortical neuronal responses to NMDA and improved attentional set-shifting performance in rats following prebiotic (B-GOS) ingestion (Gronier et al, 2018)
  • In vitro fermentation of B-GOS: impact on faecal bacterial populations and metabolic activity in autistic and non-autistic children (Grimaldi et al, 2017)
  • Prebiotic administration normalizes lipopolysaccharide (LPS)-induced anxiety and cortical 5-HT2A receptor and IL1-β levels in male mice (Savignac et al, 2016)
  • Neonatal prebiotic (B-GOS) supplementation increases the levels of synaptophysin, GluN2A‐subunits and BDNF proteins in the adult rat hippocampus (Williams et al, 2016)
  • Prebiotic intake reduces the waking cortisol response and alters emotional bias in healthy volunteers (Schmidt et al, 2015)
  • Prebiotic administration normalizes lipopolysaccharide (LPS)-induced anxiety and cortical 5-HT2A receptor and IL-1β levels in male mice (Savignac, 2013)

    • Travellers' Diarrhoea

  • Can a galacto-oligosaccharide reduce the risk of traveller’s diarrhoea? A placebo-controlled, randomized, double-blind study (Hasle et al, 2017)
  • A double-blind, placebo-controlled, randomized human study assessing the capacity of a novel galactooligosaccharide mixture in reducing travellers' diarrhoea (Drakoularakou et al, 2010)

    • Immune Response

  • Human Milk Oligosaccharides and Synthetic Galactosyloligosaccharides Contain 3'-, 4-, and 6'- Galactosyllactose and Attenuate Inflammation in Human T84, NCM-460, and H4 Cells and Intestinal Tissue Ex Vivo (Newburg et al, 2016)
  • Influence of galacto-oligosaccharide mixture (B-GOS) on gut microbiota, immune parameters and metabonomics in elderly persons (Vulevic et al, 2015)
  • A Mixture of trans-Galactooligosaccharides Reduces Markers of Metabolic Syndrome and Modulates the Fecal Microbiota and Immune Function of Overweight Adults (Vulevic et al, 2013)
  • Modulation of the fecal microflora profile and immune function by a novel trans-galactooligosaccharide mixture (B-GOS) in healthy elderly volunteers (Vulevic et al, 2008)
  • Human Milk Oligosaccharides and Synthetic Galactosyloligosaccharides Contain 3'-, 4-, and 6'- Galactosyllactose and Attenuate Inflammation in Human T84, NCM-460, and H4 Cells and Intestinal Tissue Ex Vivo (Newburg et al, 2016)
  • Influence of galacto-oligosaccharide mixture (B-GOS) on gut microbiota, immune parameters and metabonomics in elderly persons (Vulevic et al, 2015)
  • A Mixture of trans-Galactooligosaccharides Reduces Markers of Metabolic Syndrome and Modulates the Fecal Microbiota and Immune Function of Overweight Adults (Vulevic et al, 2013)
  • Modulation of the fecal microflora profile and immune function by a novel trans-galactooligosaccharide mixture (B-GOS) in healthy elderly volunteers (Vulevic et al, 2008)

    • Anti-Pathogenic Effects

  • Purified galactooligosaccharide, derived from a mixture produced by the enzymic activity of Bifidobacterium bifidum, reduces Salmonella enterica serovar Typhimurium adhesion and invasion in vitro and in vivo (Searle et al, 2010)
  • A mixture containing galactooligosaccharide, produced by the enzymic activity of Bifidobacterium bifidum, reduces Salmonella enterica serovar Typhimurium infection in mice (Searle et al, 2009)
  • Modulation of anti-pathogenic activity in canine-derived Lactobacillus species by carbohydrate growth substrate (Tzortzis et al, 2005)

    • Prebiotic Activity

  • Colonic gas homeostasis: Mechanisms of adaptation following HOST-G904 galactooligosaccharide use in humans (Mego et al, 2017)
  • Metabolic adaptation of colonic microbiota to galactooligosaccharides: a proof-of-concept-study (Mego et al, 2017)
  • Prebiotic evaluation of a novel galactooligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIMB 41171, in healthy humans: a randomized, double-blind, crossover, placebo controlled intervention study (Depeint et al, 2008)

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