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Candida albicans is a semi-ubiquitous pathobiont that is known to significantly impact human health and wellbeing, causing a significant financial strain on the medical system. Due to increasing antifungal resistance, there is a growing need for novel fungal therapeutics to treat diseases caused by this fungus. The development and use of Live Biotherapeutic Products (LBPs) is an innovative and novel approach to potentially treating Candidiasis and other comorbidities associated with C. albicans infection. To evaluate their anti-pathogenic efficacy, it is necessary to understand the underlying mechanisms involved, via the use of biomimetic cell models. In this study, six LBPs were chosen to investigate their competitive inhibitory effect against C. albicans using a co-culture of Caco-2 cells and mucous-secreting HT29-MTX cells to mimic human gut epithelium. The LBP strains were supplied by Servatus Biopharmaceuticals and identified as SVT 01D1, SVT 04P1, SVT 05P2, SVT 06B1, SVT 07R1 and SVT 08Z1. Five out of the six LBPs showed a significant reduction in the adhesion of C. albicans and all six LBPs reduced C. albicans invasion in the co-culture cells to varying degrees. There was no significant difference between co-inoculation of C. albicans with the LBPs or pre-inoculation of LBPs before the addition of C. albicans. The potential of these LBPs as novel anti-fungal therapeutics for the treatment of C. albicans diseases can be further documented in clinical trials.

Aims The aim of the present study was to examine the safety and efficacy of a formulated Ayurvedic botanical combination in reducing vasomotor and other menopause-associated symptoms in otherwise healthy women. Methods This was a double-blind, randomized, placebo-controlled trial conducted with 117 healthy women, aged 40 to 65 years using a formulated Ayurvedic medicine composed of 75 mg Tinospora Cardifolia, 100 mg Asparagus racemosus, 100 mg Withania somnifera and 225 mg Commiphora mukul per capsule, administered as one capsule twice per day over a period of 12 weeks. The primary outcome measure was menopausal symptoms assessed by the validated Menopause-Specific Quality of Life (MENQOL) questionnaire. The secondary outcome measures included a patient-reported diary of vasomotor symptoms, serum hormone levels and health indices (body weight, blood pressure, haematological and biochemistry markers). Results A significant difference was demonstrated for the total MENQOL score and the vasomotor (p

Trigonella foenum-graecum seed extract has demonstrated hormone modulatory activity, providing biological plausibility for relieving menopausal symptoms. The study aimed to assess efficacy of a standardized T. foenum-graecum de-husked seed extract in reducing menopausal symptoms in healthy aging women. The study was a double-blind, randomized, placebo-controlled trial that recruited 115 women aged 40 to 65 years of which 59 were allocated to active (n = 54 completed) and 56 to placebo (n = 50 completed). Active treatment was T. foenum-graecum de-husked seed extract, 600 mg per day for 12 weeks. Outcome measures included Menopause-Specific Quality of Life (MENQOL) questionnaire, frequency of hot flushes and night sweats and serum estradiol levels. There was a significant reduction in menopausal symptoms in the active group compared with placebo as assessed by total MENQOL score (p

The existence of an implicit living microscopic world, composed primarily of bacteria, has been known for centuries. The exact mechanisms that govern the contribution of bacteria to human health and disease have only recently become the subject of intense research efforts. Within this very evident shift in paradigms, the rational design of probiotic formulations has led to the creation of an industry that seeks to progress the engineering of probiotic bacteria that produce metabolites that may enhance human host health and prevent disease. The promotion of probiotics is often made in the absence of quality scientific and clinically plausible data. The latest incursions into the probiotic market of claims have posited the amelioration of oxidative stress via potent antioxidant attributes or limiting the administration of probiotics to those species that do not produce D-Lactic acid (i.e., claims that D-Lactic acid acidosis is linked to chronic health conditions) or are strain-specific (shaping an industry point of difference) for appraising a therapeutic effect. Evidence-based research should guide clinical practice, as there is no place in science and medicine that supports unsubstantiated claims. Extravagant industry based notions continue to fuel the imprimatur of distrust and skepticism that is leveled by scientists and clinicians at an industry that is already rife with scientific and medical distrust and questionable views on probiotics. Ignoring scientifically discordant data, when sorting through research innovations and false leads relevant to the actions of probiotics, drives researcher discomfit and keeps the bar low, impeding the progress of knowledge. Biologically plausible posits are obligatory in any research effort; companies formulating probiotics often exhibit a lack of analytical understanding that then fuels questionable investigations failing to build on research capacity.

Early treatment may prevent or delay the onset of type 2 diabetes mellitus (T2DM) in individuals who are at high risk. Lifestyle interventions and the hypoglycemic drug metformin have been shown to reduce T2DM incidence. The effectiveness of such interventions may be enhanced by targeting environmental factors such as the intestinal microbiota, which has been proven to predict the response to lifestyle interventions and play a part in mediating the glucose-lowering effects of metformin. Shifts in the intestinal microbiota &ldquo, towards a more balanced state&rdquo, may promote glucose homeostasis by regulating short-chain fatty acids&rsquo, production. This study aimed to investigate the safety and effect of a multi-strain probiotic on glycemic, inflammatory, and permeability markers in adults with prediabetes and early T2DM and to assess whether the probiotic can enhance metformin&rsquo, s effect on glycaemia. A randomised controlled pilot study was conducted in 60 adults with a BMI &ge, 25 kg/m2 and with prediabetes or T2DM (within the previous 12 months). The participants were randomised to a multi-strain probiotic (L. plantarum, L. bulgaricus, L. gasseri, B. breve, B. animalis sbsp. lactis, B. bifidum, S. thermophilus, and S. boulardii) or placebo for 12 weeks. Analyses of the primary outcome (fasting plasma glucose) and secondary outcomes, including, but not limited to, circulating lipopolysaccharide, zonulin, and short chain fatty acids and a metagenomic analysis of the fecal microbiome were performed at baseline and 12 weeks post-intervention. The results showed no significant differences in the primary and secondary outcome measures between the probiotic and placebo group. An analysis of a subgroup of participants taking metformin showed a decrease in fasting plasma glucose, HbA1c, insulin resistance, and zonulin, an increase in plasma butyrate concentrations, and an enrichment of microbial butyrate-producing pathways in the probiotic group but not in the placebo group. Probiotics may act as an adjunctive to metformin by increasing the production of butyrate, which may consequently enhance glucose management.

Major depression is a prevalent mental health disorder and a proportion of patients do not respond adequately to standard treatment. The use of nutraceutical adjunctives with antidepressant medication such as high dose S-adenosylmethionine (SAMe) has proven beneficial in terms of initial symptom response but the effect on symptom maintenance and relapse is unknown. In this pilot study [n = 36], participants [26 evaluable subjects] with established sub-optimal response to treatment for major depressive disorder and who were prescribed Selective Serotonin Reuptake Inhibitor (SSRI) medication were randomly allocated to either 1600 mg or 800 mg daily of SAMe for 15 weeks duration to evaluate the efficacy on both symptom response and maintenance. A variety of validated psychiatric measures of symptoms and mood including clinician assessment and self-report measures were used to assess outcome measures. Both SAMe doses achieved similar results with a significant proportion of participants (35%) achieving significant symptom improvement at the end of 15 weeks supplementation as assessed by the Beck Depression Inventory (BDI), Outcome Questionnaire 45 (OQ45), and improved Quality of Life (QOL) scores. After a 2 week washout period, SAMe non-responders were then supplemented with 1600 mg of Magnesium Orotate for 8 weeks duration which resulted in significant clinical improvement as measured by BDI, OQ45 and QOL scores [n = 8]. We progress the SAMe-methylation and Orotate–uridine hypothesis and consider that the response to these novel compounds implicates the microbiome as an important agent for the adjunctive treatment of sub-optimal response to pharmaceutical medications.

The microbiome located in the human gastrointestinal tract (GIT) comprises the largest community (diverse and dense) of bacteria, and in conjunction with a conducive internal milieu, promotes the development of regulated pro- and anti-inflammatory signals within the GIT that promotes immunological and metabolic tolerance. In addition, host-microbial interactions govern GIT inflammation and provide cues for upholding metabolic regulation in both the host and microbes. Failure to regulate inflammatory responses can increase the risk of developing inflammatory conditions in the GIT. Here, we review clinical studies regarding the efficacy of probiotics/prebiotics and the role they may have in restoring host metabolic homeostasis by rescuing the inflammatory response. The clinical studies reviewed included functional constipation, antibiotic-associated diarrhoea, Clostridium difficile diarrhoea, infectious diarrhoea/gastroenteritis, irritable bowel syndrome, inflammatory bowel diseases and necrotizing enterocolitis. We have demonstrated that there was an overall reduction in risk when probiotics were administered over placebo in the majority of GIT inflammatory conditions. The effect size of a cumulative reduction in relative risk for the GIT conditions/diseases investigated was 0.65 (0.61-0.70) (z = 13.3); p < 0.0001 that is an average reduction in risk of 35 % in favour of probiotics. We also progress a hypothesis that the GIT comprises numerous micro-axes (e.g. mucus secretion, Th1/Th2 balance) that are in operational homeostasis; hence probiotics and prebiotics may have a significant pharmacobiotic regulatory role in maintaining host GIT homeostasis in disease states partially through reactive oxygen species signalling.

Childhood obesity is a predisposing factor for chronic diseases both in the adolescent years and into adulthood. Current research efforts have focused on host and environmental factors that may affect energy balance. This has lead to a plausible, biological postulation that an obese microbiota profile may exist and may demonstrate increased energy yielding behaviour by such bacteria. Consequently, the gastrointestinal tract (GIT) microbiota is gaining significant research interest in relation to obesity in an attempt to better understand the aetiology of obesity and potentially new methods of treatment. It is now well known that the microbiota that colonise the GIT perform a number of functions that include regulating the normal development and function of the mucosal barriers; assisting with maturation of immunological tissues, which in turn promotes immunological tolerance to antigens from foods, the environment, or potentially pathogenic organisms; chemical communication and influence of target tissues such as the liver, brain, muscle, adipose tissue, heart and GIT; preventing propagation of pathogenic microorganisms as well as controlling nutrient uptake and metabolism. Here we develop a hypothesis that multi-strain probiotics may provide a potential therapeutic role when supplemented conjointly with lifestyle interventions for obese children/adolescents. The administration of multi–strain probiotics in conjunction with lifestyle measures may rescue the GIT obese microbiome phenotype and encourage the re-establishment of a microbiome towards one that resembles that of lean individuals.

Clinical data demonstrating efficacy for nutraceutical compounds marketed for the symptom relief of osteoarthritis (OA) have been largely contentious. Furthermore, no association has been linked between clinical trial inconsistencies and gastrointestinal (GI) dysfunction. The aim of this study was to primarily investigate the efficacy of a high-dose New Zealand green-lipped mussel (GLM) extract in patients diagnosed with OA of the knee and concurrently assess GLM impact on GI function.An open label, single group allocation study was conducted, that administered 3,000 mg/day of GLM extract over 8 weeks to 21 subjects diagnosed with knee OA. Outcome measures were scored using the WOMAC, the Lequesne algofunctional index, and the Gastrointestinal Symptom Rating Scale (GSRS) tools. An intention-to-treat analysis was employed and subject data collected at T₀, T₄ and T₈ weeks.Paired t tests showed significant improvement for the Lequesne, WOMAC (p0.001) and GSRS (p = 0.005) scores. A repeated measures ANOVA analysis showed significant improvement in scores for the Lequesne (F = 20.317, p0.001), WOMAC (F = 28.383, p0.001) and the GSRS (F = 9.221, p = 0.002).Green-lipped mussel significantly improved knee joint pain, stiffness and mobility. We report for the first time that the administration of GLM extract also significantly improved GI symptoms by 49% in OA patients. Given that GI dysfunction is linked to analgesic medication use, we further conclude that the therapeutic efficacy of the GLM extract used was possibly correlated to its effects on GI function by improving GSRS scores from baseline. Results from this trial highlight the requisite for further clinical investigations of gastrointestinal tract function in OA patients.

Perna canaliculus (Green-Lippped Mussel) is found only in New Zealand waters and is cultivated and manufactured for both the food and nutraceutical industry world-wide. P. canaliculus has traditionally been used as a therapeutic to treat various arthralgias in both humans and animals; however, clinical research reports provide conflicting results. Numerous in vitro studies have reported anti-inflammatory activity of the mussel under various conditions and also demonstrated a synergistic effect with pharmaceutical medications such as non-steroidal anti-inflammatory drugs (NSAIDs) with P. canaliculus protecting the gastrointestinal mucosal lining against such medications. It is proposed that the anti-inflammatory activity demonstrated by P. canaliculus is predominantly due to the lipid fraction, however, among the major classes of compounds found in mussel meat, proteins and peptides are the largest with isolates demonstrating various anti-microbial, anti-inflammatory, anti-oxidant, bioadhesive and anti-hypertensive activities. A review of the bioactive components, their function and therapeutic application is outlined in this chapter. Furthermore, we hypothesise and provide supportive evidence that the gastrointestinal microbiota play an important role in disease processes such as Rheumatoid arthritis and Osteoarthritis and also in the efficacy of P. canaliculus in chronic inflammatory conditions. The metabolic capacity of intestinal microbiota can modify bioactive food components altering the hosts' exposure to these components, potentially enhancing or diminishing their health effects. Understanding the interaction of the bioactive compounds in P. canaliculus with commensal and pathogenic bacteria may facilitate the development of novel interventions to control intestinal and extraintestinal inflammation.

Bacteria represent the earliest form of independent life on this planet. Bacterial development has included cooperative symbiosis with plants (e.g., Leguminosae family and nitrogen fixing bacteria in soil) and animals (e.g., the gut microbiome). It is generally agreed upon that the fusion of two prokaryotes evolutionarily gave rise to the eukaryotic cell in which mitochondria may be envisaged as a genetically functional mosaic, a relic from one of the prokaryotes. This is expressed by the appearance of mitochondria in eukaryotic cells (an alpha-proteobacteria input), a significant endosymbiotic evolutionary event. As such, the evolution of human life has been complexly connected to bacterial activities. Hence, microbial colonization of mammals has been a progressively driven process. The interactions between the human host and the microbiome inhabiting the gastrointestinal tract (GIT) for example, afford the human host the necessary cues for the development of regulated signals that in part are induced by reactive oxygen species (ROS). This regulated activity then promotes immunological tolerance and metabolic regulation and stability, which then helps establish control of local and extraintestinal end-organ (e.g., kidneys) physiology. Pharmacobiotics, the targeted administration of live probiotic cultures, is an advancing area of potential therapeutics, either directly or as adjuvants. Hence the continued scientific understanding of the human microbiome in health and disease may further lead to fine tuning the targeted delivery of probiotics for a therapeutic gain.

A recent study investigating faecal transplants to eliminate Clostridium difficile infections has elicited further interest regarding the pharmacobiotic potential of the human gastrointestinal microbiome. Probiotic preparations may exhibit significant potential for the treatment of CDAD. Probiotics are defined as living organisms in food and dietary supplements that, upon ingestion, can improve the health of the host beyond their inherent basic nutritional content. The human–microbial gastrointestinal tract (GIT) interface is an ecosystem that participates in a variety of important roles in human health and disease. Maintaining this ecosystem in a balanced state is a critical requisite for the control of pathogenic bacteria and the associated toxin load produced in the small and large bowel. Pharmacotherapy induced adverse metabolic conditions that ensue can disrupt the GIT homeostasis and contribute toward a dysbiotic burden that increases the risk of CDAD.

Key learning points An 84-year-old woman of Afro-Caribbean origin presented to the emergency department following a collapse at her home. She gave a one-month history of decreased appetite and unintentional weight loss, and her family had noted a general decline in her mobility and well-being

Perna canaliculus (Green-Lippped Mussel) is found only in New Zealand waters and is cultivated and manufactured for both the food and nutraceutical industry world-wide. P. canaliculus has traditionally been used as a therapeutic to treat various arthralgias in both humans and animals; however, clinical research reports provide conflicting results. Numerous in vitro studies have reported anti-inflammatory activity of the mussel under various conditions and also demonstrated a synergistic effect with pharmaceutical medications such as non-steroidal anti-inflammatory drugs (NSAIDs) with P. canaliculus protecting the gastrointestinal mucosal lining against such medications. It is proposed that the anti-inflammatory activity demonstrated by P. canaliculus is predominantly due to the lipid fraction, however, among the major classes of compounds found in mussel meat, proteins and peptides are the largest with isolates demonstrating various anti-microbial, anti-inflammatory, anti-oxidant, bioadhesive and anti-hypertensive activities. A review of the bioactive components, their function and therapeutic application is outlined in this chapter. Furthermore, we hypothesise and provide supportive evidence that the gastrointestinal microbiota play an important role in disease processes such as Rheumatoid arthritis and Osteoarthritis and also in the efficacy of P. canaliculus in chronic inflammatory conditions. The metabolic capacity of intestinal microbiota can modify bioactive food components altering the hosts' exposure to these components, potentially enhancing or diminishing their health effects. Understanding the interaction of the bioactive compounds in P. canaliculus with commensal and pathogenic bacteria may facilitate the development of novel interventions to control intestinal and extraintestinal inflammation.

Bacteria represent the earliest form of independent life on this planet. Bacterial development has included cooperative symbiosis with plants (e.g., Leguminosae family and nitrogen fixing bacteria in soil) and animals (e.g., the gut microbiome). It is generally agreed upon that the fusion of two prokaryotes evolutionarily gave rise to the eukaryotic cell in which mitochondria may be envisaged as a genetically functional mosaic, a relic from one of the prokaryotes. This is expressed by the appearance of mitochondria in eukaryotic cells (an alpha-proteobacteria input), a significant endosymbiotic evolutionary event. As such, the evolution of human life has been complexly connected to bacterial activities. Hence, microbial colonization of mammals has been a progressively driven process. The interactions between the human host and the microbiome inhabiting the gastrointestinal tract (GIT) for example, afford the human host the necessary cues for the development of regulated signals that in part are induced by reactive oxygen species (ROS) . This regulated activity then promotes immunological tolerance and metabolic regulation and stability, which then helps establish control of local and extraintestinal end-organ (e.g., kidneys) physiology. Pharmacobiotics , the targeted administration of live probiotic cultures, is an advancing area of potential therapeutics, either directly or as adjuvants. Hence the continued scientific understanding of the human microbiome in health and disease may further lead to fine tuning the targeted delivery of probiotics for a therapeutic gain.

To investigate how changes in the gastrointestinal tract (GIT) microbiota profile may influence nutraceutical efficacy in osteoarthritis (OA) and allow the formulation of a hypothesis that explains in part the inconsistent and contentious findings from OA clinical studies with green-lipped mussel (GLM) and glucosamine.A non-blinded randomised clinical trial was conducted with 38 subjects diagnosed with knee OA. Each participant received either 3,000 mg/day of a whole GLM extract or 3,000 mg/day of glucosamine sulphate (GS), p.o. for 12 weeks. Faecal microbial analyses were carried out after collecting stools at T (0) and T (12) weeks. Additional pharmacometric measures were obtained from changes in arthritic scores in the Western Ontario McMaster Universities Arthritis Index (WOMAC) and the Lequesne algofunctional indices and the Gastrointestinal Symptom Rating Scale (GSRS). An intention-to-treat analysis was employed and participant data collected at T (0), T (6) and T (12) weeks.There were no statistically significant changes in bacterial growth patterns determined by the Wilcoxon test. In both groups there was a trend towards a decrease in Clostridium and Staphylococcus species and increase in Lactobacillus, Streptococcus and Eubacterium species. In the GLM group Bifidobacterium tended to increase and Enterococcus and yeast species to decrease. The GS-treated group demonstrated a trend towards a decrease in Bacteroides and an increase in yeasts and Coliforms species, most notably Escherichia coli. We further confirm significant improvement (p0.05) in all OA outcome measures from T (0) to T (12) weeks for both the GLM and GS groups. The GSRS scores indicated that GIT function significantly improved over the 12 weeks duration with GLM and GS supplementation.Both GLM and GS reduced OA symptoms and non-significantly altered the gut microbiota profile from baseline. Changes in the microbiota profiles occurred in both treatment groups; the most notable being a reduction in the Clostridia sp. This study suggests that nutritional supplements such as GLM and GS may regulate some of the metabolic and immunological activities of the GIT microbiota. The decrease in Clostridia, a potent modulator of colonic Th17 and CD4+ regulatory T cells, was consistent with a decrease in inflammation; improved GSRS scores and OA symptoms for these OA participants. The GIT microbiota may be important factor in the first-pass metabolism of these nutraceuticals.

The aim of the clinical trial was to evaluate the efficacy and safety of ProstateEZE Max, an orally dosed herbal preparation containing Cucurbita pepo, Epilobium parviflorum, lycopene, Pygeum africanum and Serenoa repens in the management of symptoms of medically diagnosed benign prostate hypertrophy (BPH).This was a short-term phase II randomized double-blind placebo controlled clinical trial.The trial was conducted on 57 otherwise healthy males aged 40-80 years that presented with medically diagnosed BPH.The trial participants were assigned to receive 3 months of treatment (1 capsule per day) with either the herbal preparation (n = 32) or a matched placebo capsule (n = 25).The primary outcome measure was the international prostate specific score (IPSS) measured at baseline, 1, 2 and 3 months. The secondary outcomes were the specific questions of the IPSS and day-time and night-time urinary frequency.There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p0.05). The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p0.03). The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p0.004).The herbal preparation (ProstateEZE Max) was shown to be well tolerated and have a significant positive effect on physical symptoms of BPH when taken over 3 months, a clinically significant outcome in otherwise healthy men.

The aim of the study was to determine if a bovine lactoferrin/whey protein Ig-rich fraction (Lf/IgF) combination was effective in reducing the number of colds and in turn improving symptom recovery in a cohort of males and females that reported frequently contracting a cold.A double blind randomized placebo-controlled clinical trial.One-hundred and twenty-six participants matched by age, BMI, dietary and physical parameters with self-reported frequent upper respiratory tract symptoms and infections were randomly assigned to receive 600 mg of Lf/IgF or a placebo daily for 90 days.A total of 90 participants (47 receiving the active and 43 placebo) completed the 90 day trial and 15 completed 45 days participation (6 in the active and 9 in the placebo group). The total number of colds recorded over the study period was 48 for the treatment group versus 112 for the placebo group (p0.001). The significant trend was retained when the data was corrected for medications returned (p0.001) and for guessing treatment allocations (p0.001). Non-parametric analysis demonstrated that the total number of cold-associated symptoms reported by participants that received Lf/IgF was significantly less than those in the placebo group (p0.05). Also, total days sick with a cold and cold severity were reduced over the clinical trial period for Lf/IgF over placebo, but the trend was not significant.These findings demonstrate that the Lf/IgF combination significantly decreased the incidence of colds and the cumulative number of cold-related symptoms over placebo. This therapeutic combination may be indicated for the prevention of colds and its most common symptoms in the general population when administered as a preventative supplement.

Dietary interventions can assist with the management of disease symptoms that accompany rheumatoid arthritis (RA), such as pain, tender swollen joints, stiffness, and associated disability and disease progression. Dietary interventions have gained widespread appeal for both clinicians and RA patients. Interventions that promote self-help through education can have significant benefits for patients as they negotiate pain and musculoskeletal disability. There is substantial scientific evidence that demonstrates patients diagnosed with RA may benefit from dietary interventions; however, recent systematic reviews remain uncertain about the therapeutic efficacy of dietary manipulation for RA due to clinical trials with a high risk of bias. However, dietary interventions with plausible therapeutic activity may be indicated for reducing RA-associated symptoms, including elimination of foods that may trigger an allergic or intolerant response, introduction of known anti-inflammatory dietary compounds and correction of food, or drug-induced gastrointestinal tract microbiota abnormalities and permeability.

Background Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases. An evidence-based multi-species probiotic was developed to encourage a shift in the gastrointestinal bacterial cohort from a disease-prone to a balanced state with the aim of improving metabolic markers associated with type 2 diabetes mellitus. Methods Sixty adults with a body mass index ≥25 kg/m2 with prediabetes or type 2 diabetes mellitus (diagnosed within the previous 12 months) will be enrolled in a double-blind, placebo-controlled pilot study. Participants will be randomized to a multi-species probiotic or placebo for 12 weeks. Both groups will receive lifestyle and nutritional advice. The primary outcome measure is the change between groups in fasting plasma glucose levels from baseline to 12 weeks. Secondary outcome measures include, but are not limited to, the change in lipid profile, systemic inflammation, gut permeability, and faecal microbial and metabolomic profiles. Blood and stool samples are collected at baseline and 12 weeks after treatment. Discussion Intentional manipulation of gastrointestinal microbial profiles may be useful for preventing and controlling type 2 diabetes mellitus and its associated metabolic complications. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12613001378718. Registered on 16 December 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1762-x) contains supplementary material, which is available to authorized users.