Clinical Papers
Bimuno® is the result of intensive research & development dating back from 2000 and conducted in collaboration with the University of Reading’s Food Microbial Sciences Unit and other globally recognized research institutes.
The result of this research was the development of Bimuno, a multi-functional supplement based around a unique and patent- protected, galactooligosaccharide formulation. It is the only 2nd generation prebiotic and as such offers additional functionality over and above its prebiotic and bifidogenic effect.
The research which is on-going, was initially conducted using a laboratory model of the human colon in order to identify the most effective GOS structures that could potentially offer protection of the gut from infection and inflammation.
A number of clinical trials have been completed and subsequent trials will continue to be the focus of ongoing research in this very exciting area which positively affects the general wellbeing of your patients and customers.
Clinical Trials
The following Bimuno® clinical trials have been published in peer reviewed journals:
Prevention of Travellers’ Diarrhoea
Clinical trial: A double-blind, placebo-controlled, randomized human study assessing the capacity of a novel galacto-oligosaccharide mixture (B-GOS) in reducing travellers’ diarrhoea.
Background/Objectives: Prebiotics have attracted interest for their ability to positively affect the colonic microbiota composition, thus increasing resistance to infection and diarrhoeal disease. This study assessed the effectiveness of a prebiotic galacto-oligosaccharide mixture (B-GOS) on the severity and/or incidence of travellers’ diarrhoea (TD) in healthy subjects.
Subjects/Methods: The study was a placebo-controlled, randomized, double blind of parallel design in 159 healthy volunteers, who travelled for a minimum of 2 weeks to a country of low or high risk of TD.
The investigational product was the B-GOS and the placebo was maltodextrin. Volunteers were randomized into groups with an equal probability of receiving either the prebiotic or placebo. The protocol comprised of a week pre-holiday period recording bowel habit, while receiving intervention and the holiday period.
Bowel habit included the number of bowel movements and average consistency of the stools as well as occurrence of abdominal discomfort, flatulence, bloating or vomiting. A clinical report was completed in the case of diarrhoeal incidence. A post-study questionnaire was also completed by all subjects on their return.
Results: Results showed significant differences between B-GOS and the placebo group in the incidence (P<0.05) and duration (P<0.05) of TD. Similar findings occurred on abdominal pain (P<0.05) and the overall quality of life assessment (P<0.05).
Conclusions: Consumption of the tested galacto-oligosaccharide mixture showed significant potential in preventing the incidence and symptoms of TD.
Drakoularakou A et al. European Journal of Clinical Nutrition 2010;64:146-152.
Download a PDF copy of the full study here
Prevention of symptoms of Irritable Bowel Syndrome
Clinical trial: The effects of a trans-galacto-oligosaccharide (B-GOS) prebiotic on faecal microbiota and symptoms in irritable bowel syndrome.
Background: Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS).
Aim: to investigate the efficacy of a novel prebiotic trans-galactooligosaccharide (B-GOS) in changing colonic microflora and improve the symptoms in IBS sufferers.
Methods: In all 44 patients with Rome II positive IBS completed a 12 week single centre parallel crossover controlled clinical trial. Patients were randomized to receive either 3.5g/d prebiotic, 7g/d prebiotic or 7 g/d placebo.
IBS symptoms were monitored weekly and scored according to a 7 point Likert scale. Changes in faecal microflora, stool frequency and form (Bristol stool scale) subjective global assessment (SGA), anxiety and depression and QOL scores were also monitored.
Results: The prebiotic significantly enhanced faecal bifidobacteria (3.5g/d P<0.005; 7g/d P<0.001). Placebo was without effect on the clinical parameters monitored, while the prebiotic at 3.5g/d significantly changed stool consistency (P<0.05), improved flatulence (P<0.05), bloating (P<0.05), composite score of symptoms (P<0.05) and SGA (P<0.05). The prebiotic at 7g/d significantly improved SGA (P<0.05) and anxiety scores.
Conclusion: The galactooligosaccharide acted as a prebiotic in specifically stimulating gut bifidobacteria in IBS patients and is effective in alleviating symptoms. These findings suggest that the prebiotic has potential as a therapeutic agent.
Silk DBA et al. Aliment Pharmacol Ther 2009;29:508-518.
Download a PDF copy of the full study here
Enhancing Immune Function in the Elderly
Clinical Trial: Modulation of the faecal microflora profile and immune function by a novel trans-galactooligosaccharide mixture (B-GOS) in healthy elderly volunteers.
Background: Aging is associated with reduced numbers of beneficial colonic bifidobacteria and impaired immunity. Galactooligosaccharides (GOSs) stimulate the growth of bifidobacteria in younger adults, but little is known about their effects in the elderly and their immunomodulatory capacity.
Objective: We assessed the effect of a prebiotic GOS mixture (B-GOS) on immune function and faecal microflora composition in healthy elderly subjects.
Design: In a double-blind, placebo-controlled, crossover study, 44 elderly subjects were randomly assigned to receive either a placebo or the B-GOS treatment (5.5g/d). Subjects consumed the treatments for 10 weeks, and then went through a 4 week washout period, before switching to the other treatment for the final 10 weeks.
Blood and faecal samples were collected at the beginning, middle (5 weeks), and end of the test period.
Predominant bacterial groups were quantified, and phagocytocis, natural killer (NK) cell activity, cytokine production, plasma cholesterol, and HDL cholesterol were measured.
Results: B-GOS significantly increased the numbers of beneficial bacteria, especially bifidobacteria, at the expense of less beneficial groups compared with baseline and placebo. Significant increase in phagocytosis, NK cell activity, and the production of anti-inflammatory cytokine interleukin-10 (IL-10) and significant reduction in the production of pro-inflammatory cytokines (IL-6, IL-1β, and tumour necrosis factor-α) were observed. B-GOS exerted no effects on total cholesterol or HDL-cholesterol production, however.
Conclusions: B-GOS administration to healthy elderly persons resulted in positive effects on both the microflora composition and the immune response. Therefore, B-GOS may be a useful dietary candidate for the enhancement of gastro-intestinal health and immune function in elderly persons.
Vulevic J et al. Am J Clin Nutr 2008;88:1438-46.
Download a PDF copy of the full study here
Prebiotic and Bifidogenic (immunity boosting) effect in Healthy Humans
Clinical Trial: Prebiotic evaluation of a novel galactooligosaccharide mixture (B-GOS) produced by the enzymatic activity of Bifidobacterium bifidum NCIMB 41171, in healthy humans: a randomized, double-blind, crossover, placebo-controlled intervention study.
Background: Galactooligosaccharides are selectively fermented by the beneficial member of the colonic microflora contributing to the health of the host.
Objective: We assessed the prebiotic potential of a novel galactooligosaccharide produced through the action of β-galactosidases, originating from a probiotic Bifidobacterium bifidum strain, against a galactooligosaccharide produced through the action of an industrial β-galactosidase and a placebo.
Design: Fifty-nine healthy human volunteers participated in this study. Initially, the effect of the matrix on the prebiotic properties of a commercially available galactooligosaccharide (7g/d) was assessed during 7 day treatment periods and a 7 day washout period in between. During the second phase, 30 volunteers were assigned to a sequence of treatments (7 days) differing in the amount of the novel galactooligosaccharide (0, 3.6, or 7g/d). Stools were recovered before and after each intervention, and bacteria numbers were determined by fluorescent in situ hybridization.
Results: Addition of the novel galactooligosaccharide mixture significantly increased the bifidobacterial population ratio compared with the placebo (P<0.05), whereas 7 g/d of the novel galactooligosaccharide significantly increased the bifidobacterial ratio compared with the commercial galactooligosaccharide (P<0.05). Moreover, a significant relation (P<0.001) between the bifidobacteria proportion and the novel galactooligosaccharide dose (0, 3.6, and 7g.d) was observed. This relationship was similar to the effect of the novel galactooligosaccharide on the prebiotic index of each dose.
Conclusions: This study showed that the galactooligosaccharide mixture produced with different β-galactosidases show different prebiotic properties and that, by using enzymes originating from bifidobacterial species, an increase in the bifidogenic properties of the prebiotic product is achievable.
Depeint F et al. Am J Clin Nutr 2008;87:785-91
Download a PDF copy of the full study here
Reduction of Colonization and Pathology associated with Salmonella Typhimurium Infection
Study: A mixture containing galactooligosaccharide (B-GOS), produced by the enzymatic activity of Bifidobacterium bifidum, reduces Salmonella enterica serovar Typhimurium infection in mice.
Background: The prebiotic Bimuno® is a mixture containing galactooligosaccharide, produced by the galactosyltransferase activity of Bifidobacterium bifidum NCIMB 41171 in the presence of lactose. Previous studies have implicated prebiotics in reducing infections by enteric pathogens, thus it was hypothesized that Bimuno® may confer some protection in the murine host from Salmonella enterica serovar Typhimurium (S. Typhimurium) infection.
Design: In this study, infection caused by S. Typhimurium SL 1344nal in the presence or absence of Bimuno® was assessed using tissue culture assays, a murine ligated ileal gut loop model and a murine oral challenge model.
Results: In tissue culture adherence and invasion assays with HT-29-16E cells, the presence of ~2mM Bimuno® significantly reduced the invasion of S. Typhimurium SL 1344nal (P<0.0001).
In the murine ligated ileal gut loops, the presence of Bimuno® prevented colonization and the associated pathology of S. Typhimurium. In the BALB/c mouse model, the oral delivery of Bimuno® prior to challenge with S. Typhimurium resulted in significant reductions in colonization in the five organs sampled, with highly significant reductions being observed in the spleen at 72 and 96 h post-challenge (P=0.0002, P<0.0001, respectively).
Conclusion: Collectively, the results indicate that Bimuno® significantly reduced the colonization and pathology associated with S. Typhimurium infection in a murine model system, possibly by reducing the invasion of the pathogen into host cells.
Searle LEJ et al. Journal of Medical Microbiology 2009;58:37-48
Download a PDF copy of the full study here
Prebiotic and Bifidogenic (immunity boosting) effect and Anti-Pathogenic effect against Enterohepatic E.coli and Salmonella Typhimurium
Study: A novel galactooligosaccharide mixture (B-GOS) increases the fermentation system and in the proximal colonic contents of pigs in-vivo.
Background: Prebiotics are nondigestible food ingredients that encourage proliferation of selected groups of the colonic microflora, thereby altering the composition towards a more beneficial community.
Design: In the present study, the prebiotic potential of a novel galactooligosaccharide GOS (B-GOS) mixture, produced by the activity of galactosyltransferases from Bifidobacterium bifidum 41171 on lactose, was assessed in-vitro and in a parallel continuous randomised pig trial.
In situ fluorescent hybridization with 16S rRNA-targeted probes was used to investigate changes in total bacteria, Bifidobacteria, lactobacilli, bacteroides, and Clostridium histolyticum group in response to supplementing the novel GOS (B-GOS) mixture.
Results: In a three stage continuous culture system, the Bifidobacterial numbers for the first 2 vessels, which represented the proximal and traverse colon, increased (P<0.05) after the addition of the oligosaccharide mixture. In addition, then oligosaccharide mixture strongly inhibited the attachment of enterohepatic Escherichia coli (P<0.01) and Salmonella enterica serotype Typhimurium (P<0.01) to HT29 cells.
Conclusion: Addition of the novel mixture at 4% (wt:wt) to a commercial diet increased the density of Bifidobacteria (P<0.001) and the acetate concentration (P<0.001), and decreased the pH (P<0.001) compared with the control diet and the control diet supplement with inulin, suggesting a great prebiotic potential for the novel oligosaccharide mixture.
Tzortzis et al. J Nutr 2005;135:1726-1731
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Development and functional properties of Bimuno®: a second-generation prebiotic mixture
Abstract
Prebiotic carbohydrates are recognised for their ability to selectively increase the levels of health-promoting bacteria, mainly bifidobacteria and lactobacilli, in the intestine of humans and animals. Second-generation prebiotics refer to prebiotic compounds that have multiple biological health activities within the colonic environment, beyond the stimulation of bifidobacteria and lactobacilli at genus level. Using enzyme biotechnology, we have developed a unique second-generation prebiotic galacto-oligosaccharide (GOS) mixture through the action of enzymes from a probiotic bacterium, Bifidobacterium bifidum NCIMB 41171, on lactose. The produced GOS mixture (Bimuno®), which contains GOS in β- and α-anomeric configuration, has been evaluated in placebo-controlled clinical trials in terms of modulation of the colonic microbiota and specifically the colonic bifidobacteria population; protection against common gastrointestinal pathogen infections through its anti-adhesive properties and immune modulating effects has been achieved. In vitro fermentation and tissue models have been used to identify the underlying mechanisms of action, which suggest that the health enhancement properties of the specific GOS mixture are not attributed only to the beneficial effect on the colonic microbiota but also to the direct interaction of specific carbohydrate structures present in the GOS mixture with the host.
Tzortzis G (2009) Functional Foods 6 (7) 81–89