Probiotics in Cosmetic and Personal Care Products: Trends and Challenges.

Probiotics, defined as "live microorganisms that, when administered in adequate amounts, confer a health benefit on the host," are becoming increasingly popular and marketable. However, too many of the products currently labelled as probiotics fail to comply with the defining characteristics. In recent years, the cosmetic industry has increased the number of products classified as probiotics. While there are several potential applications for probiotics in personal care products, specifically for oral, skin, and intimate care, proper regulation of the labelling and marketing standards is still required to guarantee that consumers are indeed purchasing a probiotic product. This review explores the current market, regulatory aspects, and potential applications of probiotics in the personal care industry.

Probiotics for vaginal health in South Africa: what is on retailers' shelves?

BACKGROUND: Probiotics are widely used to improve gastrointestinal (GI) health, but they may also be useful to prevent or treat gynaecological disorders, including bacterial vaginosis (BV) and candidiasis. BV prevalence is high in South Africa and is associated with increased HIV risk and pregnancy complications. We aimed to assess the availability of probiotics for vaginal health in retail stores (pharmacies, supermarkets and health stores) in two major cities in South Africa. METHODS: A two-stage cluster sampling strategy was used in the Durban and Cape Town metropoles. Instructions for use, microbial composition, dose, storage and manufacturers' details were recorded. RESULTS: A total of 104 unique probiotics were identified in Cape Town and Durban (66.4% manufactured locally). Cape Town had more products than Durban (94 versus 59 probiotics), although 47% were common between cities (49/104). Only four products were explicitly for vaginal health. The remainder were for GI health in adults (51.0%) or infants (17.3%). The predominant species seen overall included Lactobacillus acidophilus (53.5%), L. rhamnosus (37.6%), Bifidobacterium longum ssp. longum (35.6%) and B. animalis ssp. lactis (33.7%). Products for vaginal health contained only common GI probiotic species, with a combination of L. acidophilus/B. longum ssp. longum/B. bifidum, L. rhamnosus/L. reuteri or L. rhamnosus alone, despite L. crispatus, L. gasseri, and L. jensenii being the most common commensals found in the lower female reproductive tract. CONCLUSION: This survey highlights the paucity of vaginal probiotics available in South Africa, where vaginal dysbiosis is common. Most vaginal products contained organisms other than female genital tract commensals.

Probiotics and prevention of Clostridium difficile infection.

The role of probiotics as adjunctive measures in the prevention of Clostridium difficile infection (CDI) has been controversial. However, a growing body of evidence has suggested that they have a role in primary prevention of CDI. Elements of this controversy are reviewed and the proposed mechanisms of action, the value and cost effectiveness of probiotics are addressed with a focus on three agents, Saccharomyces boulardii, Lactobacillus rhamnosus GG and the combination of Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R, Lactobacillus rhamnosus CLR2 (Bio-K+).

Development and utility of the FDA 'GutProbe' DNA microarray for identification, genotyping and metagenomic analysis of commercially available probiotics.

AIM: Lactic acid bacteria are beneficial microbes added to many food products and dietary supplements for their purported health benefits. Proper identification of bacteria is important to assess safety as well as proper product labelling. A custom microarray (FDA GutProbe) was developed to verify accurate labelling in commercial dietary supplements. METHODS AND RESULTS: Strain-specific attribution was achieved with GutProbe array which contains genes from the most commonly found species in probiotic supplements and food ingredients. Applied utility of the array was assessed with direct from product DNA hybridization to determine (i) if identification of multiple strains in one sample can be conducted and (ii) if any lot-to-lot variations exist with eight probiotics found on the US market. CONCLUSIONS: GutProbe is a useful tool in identifying a mixture of microbials in probiotics and did reveal some product variations. In addition, the array is able to identify lot-to-lot differences in these products. These strain level attribution may be useful for routine monitoring of batch variation as part of a 'Good Manufacturing Practices' process. SIGNIFICANCE AND IMPACT OF THE STUDY: The FDA GutProbe is an efficient and reliable platform to identify the presence of microbial ingredients and determining microbe differences in dietary supplements. The GutProbe is a fast, rapid method for direct community profiling or food matrix sampling.

Probiotic characterization of potential hydrolases producing Lactococcus lactis subsp. lactis isolated from pickled yam.

The aim of this study was to characterize potential probiotic strain co-producing α-amylase and ß-galactosidase. Sixty-three strains, isolated from pickle samples were screened for their hydrolase producing capacity by utilizing different starches as carbon source. One out of 63 strains, isolated from traditionally fermented pickled yam showing maximum hydrolase activity (α-amylase (36.9 U/ml) and ß-galactosidase (42.6 U/ml)) within a period of 48 hours was identified as Lactococcus lactis subsp. lactis. Further, it was assessed for the probiotic characteristics under gastrointestinal conditions like acidic, alkaline, proteolytic enzymes, bile stress and found to exhibit tolerance to these stresses. The therapeutic potential of the isolate is implicated because of its antagonistic effect against enteric foodborne pathogens (Salmonella typhimurium, Escherichia coli 0157:H7, Staphylococcus aureus, Yersinia enterocolitica and Aeromonas hydrophila). The results of this study entail a potential applicability of the isolate in developing future probiotic foods besides the production of industrially significant hydrolases.

Cost-benefit analysis of the probiotic treatment of children hospitalized for acute diarrhea in Bangkok, Thailand.

We studied the cost-benefit of using probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum) in the treatment of 106 children hospitalized with acute diarrhea using a double-blind randomized, placebo-controlled trial. The median length of hospital stay was significantly shorter in the probiotics group than in the controlled group (2 versus 3 days, p=0.049), but the median duration of diarrhea and direct medical costs were not significantly different (4 versus 5 days, p=0.068 and 4,418.75 versus 4,778.75 Thai Baht, p=0.342). Taking into consideration parental income loss, a non-significant lower expense was seen in the probiotics group (6,800.33 versus 7,970.92 Thai Baht, p=0.177). A greater cost-benefit with the probiotic treatment is probable, but was not statistically significant in this small study. In conclusion, the probiotics tested shortened the duration of hospitalization of children with diarrhea but the total expenses were not different.

Nutraceuticals and botanicals: overview and perspectives.

The discovery, development and marketing of food supplements, nutraceuticals and related products are currently the fastest growing segments of the food industry. Functional foods can be considered part or borderline to these products and may be defined as foods or food ingredients that have additional health or physiological benefits over and above the normal nutritional value they provide. This trend is driven by several factors, mainly due to the current consumer perceptions: the first and dominant being 'Natural is good', and other secondary, such as the increasing cost of many pharmaceuticals and their negative secondary effects, the insistent marketing campaign, the increasing perception of the need of a healthy diet and its importance in the health and homeostasis organism conditions. However, the central point is that nutraceuticals, botanicals and other herbal remedies, including the entry of new functional foods, are important because of their acceptance as the novel and modern forms to benefit of natural substances. Due to the rapid expansion in this area, the development of several aspects is considered as it could influence the future of the market of these products negatively: an imbalance existing between the increasing number of claims and products on the one hand, the development of policies to regulate their application and safety on the other, rapid and valuable controls to check the composition, including the plant extracts or adulteration to improve efficacy, like the presence of synthetic drugs. It is interesting to see that, from the negative factors reported by the market analysts, a change in consumers preferences is absent. The functional properties of many plant extracts, in particular, are being investigated for potential use as novel nutraceuticals and functional foods. Although the availability of scientific data is rapidly improving, the central aspect concerns the validation of these products. The first step of this crucial aspect is the security of the composition, obtained by the useful and adapted analytical approach. On the other hand, in the first instance, security is assured by the millenary use as food of the great majority of these plants. The importance and the novelty of functional food are inherent in the possibility to renew the secure use of plants to maintain healthiness of man in novel forms of use adapted to modern times. The market of 'other substances', after the emergence of the first period of enthusiastic explosion, is entering into the maturation period, with three important arguments to face: (a) security in composition, production and sale, avoiding easy conversions or convenient approaches and favouring competence and professionalism, (b) definition of influence of metabolic aspects, including scientific validation and (c) regulatory aspects, e.g. the claims definition and relative influences. The last aspect seams to be in primis the most crucial and fundamental to the future of all the sectors. The role of European Food and Safety Authority (EFSA) in the EU market must be considered and consequences if negative decisions on 'other substances' claim will be adopted in each country's legislation.

The Development of High-Quality Multispecies Probiotic Formulations: From Bench to Market.

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. To date, there is an increasing number of commercially available products containing probiotics on the market. Probiotics have been recommended by health care professionals for reasons ranging from their long-term immunomodulatory effects to proven benefits in the management of different health conditions. For probiotic products, there are several important aspects that determine the success rate of the development from bench to market. The aim of this review is to explore how the current knowledge on microbe-microbe and host-microbe interactions can be used to develop high-quality, evidence-based probiotic formulations, specifically probiotic dietary supplements, with a focus on the selection of safe strains with relevant functional properties. In addition, we will highlight aspects of the probiotic manufacturing process that need to be considered during the product development and the subsequent manufacturing process to guarantee consistent efficacy of a probiotic product. For each high-quality probiotic formulation, it is important to screen multiple strains, and select only those strains that show relevant functional properties and that can be considered safe for human consumption. In addition, it is imperative that attention is paid to the product development and manufacturing process, and that safety and quality properties are monitored. Importantly, the beneficial effects of probiotics should be evaluated in product efficacy studies and post-marketing surveys in order to demonstrate their clinical efficacy. All these aspects need to be evaluated and validated during the development of a successful high-quality and ready-to-market probiotic.

Cost-effectiveness analysis of using probiotics, prebiotics, or synbiotics to control Campylobacter in broilers.

Campylobacter is a food safety hazard, which causes a substantial human disease burden. Infected broiler meat is a common source of campylobacteriosis. The use of probiotics, prebiotics, or synbiotics has been associated with controlling Campylobacter infections in broilers, although efficacy remains a contentiously debated issue. On-farm use of probiotics, prebiotics, or synbiotics is gaining momentum. Therefore, it is interesting to analyze the economic viability of this potential intervention to reduce Campylobacter prevalence in broilers. A normative cost-effectiveness analysis was conducted to estimate the cost-effectiveness ratio of using probiotics, prebiotics, or synbiotics in broiler production in Denmark, the Netherlands, Poland, and Spain. The cost-effectiveness ratio was defined as the estimated costs of probiotics, prebiotics, or synbiotics use divided by the estimated public health benefits expressed in euro (€) per avoided disability-adjusted life year (DALY). The model considered differences between the countries in zootechnical and economic farm performance, in import, export, and transit of live broilers, broiler meat and meat products, and in disease burden of Campylobacter-related human illness. Simulation results revealed that the costs per avoided DALY were lowest in Poland and Spain (€4,000-€30,000 per avoided DALY) and highest in the Netherlands and Denmark (€70,000-€340,000 per avoided DALY) at an efficacy ranging from 10 to 20%. In Poland and Spain, using probiotics can be classified as a moderately expensive intervention if efficacy is more than 10%, otherwise it is relatively expensive. In the Netherlands and Denmark, using probiotics is a relatively expensive intervention irrespective of efficacy. However, if probiotics, prebiotics, or synbiotics were assumed to enhance broiler performance, it would become a relatively cost-effective intervention for Campylobacter even at low efficacy levels of 1 to 10%.

Economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): study protocol.

INTRODUCTION: Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and Clostridioides difficile-associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) is a multicentre, double-blinded, randomised controlled trial comparing the efficacy of the probiotic Lactobacillus rhamnosus GG with usual care versus usual care without probiotics in preventing VAP and other clinically important outcomes in critically ill patients admitted to the ICU. METHODS AND ANALYSIS: The objective of E-PROSPECT is to determine the incremental cost-effectiveness of L. rhamnosus GG plus usual care versus usual care without probiotics in critically ill patients. E-PROSPECT will be performed from the public healthcare payer's perspective over a time horizon from ICU admission to hospital discharge.We will determine probabilities of in-ICU and in-hospital events from all patients alongside PROSPECT. We will retrieve unit costs for each resource use item using jurisdiction-specific public databases, supplemented by individual site unit costs if such databases are unavailable. Direct costs will include medications, personnel costs, radiology/laboratory testing, operative/non-operative procedures and per-day hospital 'hoteling' costs not otherwise encompassed. The primary outcome is the incremental cost per VAP prevented between the two treatment groups. Other clinical events such as CDAD, antibiotic-associated diarrhoea and in-hospital mortality will be included as secondary outcomes. We will perform pre-specified subgroup analyses (medical/surgical/trauma; age; frailty status; antibiotic use; prevalent vs no prevalent pneumonia) and probabilistic sensitivity analyses for VAP, then generate confidence intervals using the non-parametric bootstrapping approach. ETHICS AND DISSEMINATION: Study approval for E-PROSPECT was granted by the Hamilton Integrated Research Ethics Board of McMaster University on 29 July 2019. Informed consent was obtained from the patient or substitute decision-maker in PROSPECT. The findings of this study will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT01782755; Pre-results.

Beneficial microbiota. Probiotics and pharmaceutical products in functional nutrition and medicine.

The article is mainly devoted to such representatives of gut microbiota as lactic acid bacteria and bifidobacteria, with minor accent on less frequently used or new probiotic microorganisms. Positive effects in treatment and prevention of diseases by different microbial groups, their metabolites and mechanisms of action, management and market of probiotic products are considered.

Navigating changes in Clostridioides difficile prevention and treatment.

Clostridioides difficile (C. difficile, previously known as Clostridium difficile) infections are a major health care concern. The Centers for Disease Control and Prevention (CDC) estimates that C. difficile causes almost half a million illnesses in the United States yearly, and approximately 1 in 5 patients with a C. difficile infection (CDI) will experience 1 or more recurrent infections. The incidence of infection has risen dramatically in recent years, and infection severity has increased due to the emergence of hypervirulent strains. There have been noteworthy advances in the development of CDI prevention and treatment, including a growth in the understanding of the role a patient's gut microbiome plays. The 2017 Infectious Diseases Society of America (IDSA) guidelines made a significant change in treatment recommendations for first time CDI episodes by recommending the use of oral vancomycin or fidaxomicin in place of metronidazole as a first-line treatment. The guidelines also included detailed recommendations on the use of fecal microbiota transplant (FMT) in those patients who experience 3 or more recurrent CDI episodes. A number of novel therapies for the treatment of CDI are in various stages of development. Treatments currently in phase 3 trials include the antibiotic ridinilazole, the microbiome products SER-109 and RBX2660, and a vaccine. All of these agents have shown promise in phase 1 and 2 trials. Additionally, several other antibiotic and microbiome candidates are currently in phase 1 or phase 2 trials. A qualitative review and evaluation of the literature on the cost-effectiveness of treatments for CDI in the U.S. setting was conducted, and the summary provided herein. Due to the higher cost of newer agents, cost-effectiveness evaluations will continue to be critical in clinical decision making for CDI. This paper reviews the updated CDI guidelines for prevention and treatment, the role of the microbiome in new and recurrent infections, pipeline medications, and comparative effectiveness research (CER) data on these treatments. DISCLOSURES: Durham and Le have nothing to disclose. Cassano reports consulting fees from Baxter Healthcare. Peer reviewers Drs. Ami Gopalan and Mark Rubin and Ms. Kathleen Jarvis have nothing to disclose. Planners Dr. Christine L. Cooper and Ms. Susan Yarbrough have nothing to disclose.

Development of low-cost plant probiotic formulations of functional endophytes for sustainable cultivation of Coleus forskohlii.

Deployment of plant endophytes at field level is reported to make an impact on agricultural crop productivity; development and deployment of suitable crop specific plant probiotics in a suitable delivery matrix is a value-added task. In our study, we attempted to develop bioformulations of native, fungal endophytes of Coleus forskohlii to improve plant yield using two different carrier-based materials (talc and wheat bran). Initially, fungal endophytes (RF1, SF1, and SF2) were grown on sterilized wheat bran under solid state condition and their growth kinetics and pattern were analyzed by ergosterol content and scanning electron microscope, respectively. 10-day-grown fungal endophytic cultures were used for the development of two types of formulations (wheat bran and talc-based formulations) and tested for their efficacy on host plant, C. forskohlii under field conditions. Interestingly, application of wheat bran-based endophytic formulations significantly (p < 0.01) enhanced plant height (12-29%), number of branches (51-63%), root biomass (26-33%), photosynthetic pigments (32-101%), and forskolin content (35-56%) compared to talc-based formulations under field conditions. Shelf life of endophytes (RF1, SF1, and SF2) in both formulations revealed spore viability in wheat bran-based formulations for 6 months storage period as compared to talc-based formulations. Overall, the present investigation envisages developing plant probiotic bioformulations of functional endophytes of C. forskohlii to enhance root biomass and in planta forskolin content.

Industry funding effect on positive results of probiotic use in the management of acute diarrhea: a systematized review.

Several investigations have found that industry-funded studies tend to inform results favoring the sponsored products. The pressure to demonstrate that a drug or a product causes a favorable outcome may result in investigation biases from industry-funded research. One example of this could be found in the probiotic research funded by the industry. The aim of this study was to assess the effect of industry funding on positive outcomes of the use of probiotics in the management of acute diarrhea. A systematized review of clinical trials on the use of probiotics in the management of acute diarrhea was performed. The associations between the source of funding, clinical outcomes, probiotic genus, and quality of the study were assessed using the χ-test and Fisher's exact test. Sixty-six clinical trials were included; 27 were industry funded, 18 were nonindustry funded, and 21 did not disclose their funding source. There were 48 positive and 30 negative clinical outcomes. There was no significant association between the source of funding and clinical outcomes (P=0.491). No association between the rest of the studied variables and outcomes was observed either (P>0.05). In clinical trials on the use of probiotics in the management of acute diarrhea, the source of funding has no influence on positive clinical outcomes.

Saccharomyces cerevisiae and Hanseniaspora osmophila strains as yeast active cultures for potential probiotic applications.

This work allowed the evaluation of the gastrointestinal resistance of five yeasts (Saccharomyces and non-Saccharomyces) in order to assess some biotechnological characteristics linked to the potential probiotics, using a dynamic gastrointestinal simulator (simgi®). The best results obtained were for strains Saccharomyces cerevisiae 3 and Hanseniaspora osmophila 1056. Having optimised the method, the yeasts were subsequently lyophilised, and the one that showed the least loss of viability, S. cerevisiae 3, was used in a freeze-dried form to obtain a new functional food. On the other hand, some characteristics of the product were compared with those of probiotic supplements and other commercial probiotic foods. The obtained functional product showed better parameters than the rest of the samples containing yeasts which, together with the great acceptance shown after the consumer tests, means that it can be presented as a possible commercial functional product.

Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and ß-glucan to improve glycated haemoglobin, metabolic health, and general well-being in adults with pre-diabetes: study protocol for a 2 × 2 factorial design, parallel group, placebo-controlled randomized controlled trial, with embedded qualitative study and economic analysis.

BACKGROUND: The rates of pre-diabetes and type 2 diabetes mellitus are increasing worldwide, producing significant burdens for individuals, families, and healthcare systems. In New Zealand, type 2 diabetes mellitus and pre-diabetes disproportionally affect Maori, Pacific, and South Asian peoples. This research evaluates the efficacy, acceptability, and economic impact of a probiotic capsule and a prebiotic cereal intervention in adults with pre-diabetes on metabolic and mental health and well-being outcomes. METHODS: Eligible adults (n = 152) aged 18-80 years with pre-diabetes (glycated haemoglobin 41-49 mmol/mol) will be enrolled in a 2 × 2 factorial design, randomised, parallel-group, placebo-controlled trial. Computer-generated block randomization will be performed independently. Interventions are capsulated Lactobacillus rhamnosus HN001 (6 × 109 colony-forming units/day) (A) and cereal containing 4 g ß-glucan (B), placebo capsules (O1), and calorie-matched control cereal (O2). Eligible participants will receive 6 months intervention in the following groups: AB, AO1, BO2, and O1O2. The primary outcome is glycated haemoglobin after 6 months. Follow-up at 9 months will assess the durability of response. Secondary outcomes are glycated haemoglobin after 3 and 9 months, fasting glucose, insulin resistance, blood pressure, body weight, body mass index, and blood lipid levels. General well-being and quality of life will be measured by the Short-Form Health Survey 36 and Depression Anxiety Stress Scale 21 at 6 and 9 months. Outcome assessors will be blind to capsule allocation. An accompanying qualitative study will include 24 face-to-face semistructured interviews with an ethnically balanced sample from the ß-glucan arms at 2 months, participant focus groups at 6 months, and three health professional focus groups. These will explore how interventions are adopted, their acceptability, and elicit factors that may support the uptake of interventions. A simulation model of the pre-diabetic New Zealand population will be used to estimate the likely impact in quality-adjusted life years and health system costs of the interventions if rolled out in New Zealand. DISCUSSION: This study will examine the efficacy of interventions in a population with pre-diabetes. Qualitative components provide rich description of views on the interventions. When combined with the economic analysis, the study will provide insights into how to translate the interventions into practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000990325. Prospectively registered on 10 July 2017.

Probiotic formulations and applications, the current probiotics market, and changes in the marketplace: a European perspective.

Europe is a multicultural continent where the consumption of fermented milks has traditionally been high in several countries. Thus, it is no wonder that the market for fermented dairy products with probiotic bacteria has been successful. The market for food applications of probiotics is clearly larger than that for probiotics sold in capsules, sachets, and other pharmaceutical forms. Yogurt-type drinks are the fastest-growing product category, but the diversity of probiotic food applications is not limited to milk-based products. Probiotic fruit juices, berry soups, and soy- and cereal-based fermented products are also sold. Some probiotic strains that are successful in Europe are marketed globally, but there is also a variety of local probiotic strains that are key players in their limited markets. The health messages of probiotic products have focused mainly on general well-being and support of gastrointestinal microbiota. However, because of newly accepted regulation from the European Union regarding health claims, such claims will be evaluated officially, which may substantially change their content. However, more-specific product claims may also appear on the market. This article describes trends and phenomena in mainly the food sector, which covers the most-successful probiotic applications, but food supplements are also discussed.