The human microbiome influences health and disease through diverse biochemical and functional outputs (e.g., enzymes, structural proteins, metabolites, and other cellular components) that affect nearly every aspect of human physiology. Metatranscriptomics (MT), an unbiased RNA sequencing approach, is a high-throughput and high-content method that quantifies both gut microbial taxonomy and active biochemical functions. Because microbial community composition and gene expression are dynamic, understanding temporal variation in the gut metatranscriptome across multiple time scales is essential. Here, we report the temporal dynamics of gut microbiome species and functions using a large cohort (n = 6157) with a clinically validated stool MT test. We quantified microbiome stability from hours to years and assessed taxonomic and functional resilience to major luminal perturbations, such as colonoscopy bowel preparation. Longitudinal analyses of samples collected within the same day, and across days, weeks, months, and years, revealed consistently high stability in both composition and gene expression within a single day and, importantly, across an approximate six-month period. Among individuals reporting stable diets and no antibiotic exposure, taxonomic and functional profiles remained stable for up to three years. Following colonoscopy preparation, our preliminary study of the microbiome demonstrated strong resilience, returning to its pre-procedure state within one week. Overall, these findings demonstrate that the gut microbiome is generally stable over a six-month time frame, with longer-term changes occurring gradually. These findings support the robustness of stool-based MT profiling for species-level and pathway-resolved functional analysis in longitudinal research and health applications.

Metatranscriptomics (MT) has the potential to revolutionize the field of molecular diagnostics. Due to the complexity of MT diagnostic models, positive and negative control materials for specific disease indications can be difficult to obtain. Controls must often be sourced directly from patients. This introduces logistical burdens, assay variability, and limits high throughput clinical laboratory operations. To overcome this limitation, we developed a method for generating Synthetic Control (SC) samples, which duplicate the nucleic acid signature of complex clinical specimens and produce the desired test outcome. SCs can be easily and cost-effectively produced in large quantities (> 100,000 SCs per amplification cycle), enabling high throughput diagnostic testing. Here, we report the generation of Synthetic Positive Control (SPC) samples. SPCs were validated and implemented in a clinical laboratory. The SPCs produced robust positive signals (average OC risk score of 0.996) and high levels of reproducibility (%CV of 0.29%) in a high throughput automated CLIA laboratory. SCs are a novel and useful method for the generation of high quality controls for MT-based diagnostic tests, and their adoption could herald the widespread use of MT tests in molecular diagnostics.

Introduction:The portal to the gastrointestinal tract is the oral cavity, with transient and permanent microbial residents. Oral pathogens are implicated in the aetiology of several chronic conditions. To date, the role of oral health and the oral microbiota in the aetiology of pain in sensitisation disorders have not been explored. Here, we examined associations between self-reported oral health, the oral microbiome, and various pain presentations in women. Methods:Oral health in women was assessed using the WHO oral health questionnaire. Body pain, migraine, and abdominal pain were determined using validated instruments. Saliva samples were evaluated using metatranscriptomics for relative gene abundance. Demographic and clinical characteristics data were evaluated for relationships between oral health scores, pain measures, and the oral microbiota at three taxa levels. Results:Participants in the lowest quintiles for oral health were more likely to suffer migraine headaches (χ 2 = 23.24, df 4, p < 0.001) and higher body pain scores. Four oral pathogenic species were significantly associated with SF36 bodily pain (q < 0.05) after controlling for confounders. Relative abundance of Gardnerella (genus) correlated moderately with oral health scores (ρ = -0.346, q = 0.001), while Lancefieldella (genus) and Mycoplasma salivarius were associated with migraine. Discussion:Low oral health scores correlated with higher pain scores. Both were associated with higher relative abundance of oral pathobionts. This suggests a potential role for the oral microbiota in the aetiology of pain experienced by women with migraine headache and abdominal and body pain. These findings prompt consideration of an oral microbiome-nervous system axis. Trial registration:The study was registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR), registration number ACTRN12620001337965, on 11/12/2020 https://www.anzctr.org.au/, and with the World Health Organisation, UTN: U1111-1258-5108.

OBJECTIVE:To describe the composition of the gut microbiota of women living with fibromyalgia, compared with controls, and examine the relationship between fecal microbiota and clinical features of fibromyalgia. METHODS:New Zealand women meeting American College of Rheumatology fibromyalgia criteria and age-matched controls provided fecal samples and completed validated surveys assessing pain, disorders of gut-brain interaction (DGBI), headaches, sleep quality, oral health, cognition, anxiety, depression, diet, and quality of life. Metatranscriptomic analysis identified phyla, genera, and species in fecal samples. Correlation coefficients were calculated for each α-diversity metric against clinical variables. Welch's t-test or Wilcoxon rank test was applied for binary clinical variables. Generalized linear models analyzed associations in the fibromyalgia group, adjusting for age, body mass index, and diet. Data processing and analysis used R version 4.2.1, with the Benjamini-Hochberg formula controlling for false discovery rate at ≤0.10 to minimize type 1 error risk. RESULTS:No statistically significant differences were seen in the microbial expression in fecal samples of women with fibromyalgia (n = 104) compared with controls (n = 52). Significant associations among three species from the Bacteroidetes phylum and cognitive impairment were observed. Fusobacteriota was significantly associated with Rome IV(B) DGBI, specifically epigastric pain syndrome. A strong association was observed between oral microbiota in feces and upper gastrointestinal DGBI, indicating both negative and positive correlations in this population. CONCLUSION:No overall differences in fecal microbial expression were found in women with fibromyalgia. However, Bacteroidetes and Fusobacteriota phyla were significantly associated with cognitive impairment and epigastric pain syndrome, respectively.

BACKGROUND:Fibromyalgia is a complex disorder, associated with a range of symptoms, not least of which is chronic, widespread pain. Although several reports have brought the role of oral health in systemic diseases into recent focus, the oral microbiome in fibromyalgia is unexplored. The aim of this study was to compare oral health and the oral microbiome in women with fibromyalgia with that of age-matched controls. METHODS:This observational case-control study recruited adult non-smoking, non-diabetic women meeting American College of Rheumatology (ACR) 2016 fibromyalgia criteria and age-matched controls living in New Zealand. Metatranscriptomic data from salivary samples were evaluated for differences at phyla, genus and species level, with adjustment for age, BMI and added dietary sugar intake. Results were examined against self-reported oral health. RESULTS:No differences were seen in richness or diversity of oral species between the fibromyalgia (n = 106) and control (n = 52) groups. Women with fibromyalgia had significantly lower scores on measures of oral health, which were associated with subtle shifts in the core oral microbiome. Several oral genera were significantly correlated with oral health scores (q ≤ 0.05). Higher relative abundance of the periopathogens Prevotella denticola and Solobacterium moorei was apparent in women with fibromyalgia. CONCLUSION:Significant differences in oral health and the oral microbiome were seen in women with fibromyalgia. This novel discovery presents an intriguing hypothesis that invites deeper investigation into the interaction between oral health and the oral microbiome in this population, and whether these influence the aetiology and/or symptoms of fibromyalgia in women. SIGNIFICANCE:This study presents the first evidence of altered oral microbiome in women with fibromyalgia, revealing significant disparities in oral health and the microbiome. The observed overabundance of periopathogens and the underrepresentation of commensals compared to a control group suggest intriguing potential links between the oral microbiome and fibromyalgia symptoms. These findings indicate that enhancing oral health may have broader implications for disease management and lay a robust foundation for further exploration of oral-systemic interactions in fibromyalgia.

In this opinion article, we argue that the requisite scientific knowledge and technological capabilities to elucidate the fundamental causes of chronic diseases—and to develop strategies for their prevention, reversal, and cure—already exist today. However, to implement this vision, a transformative shift in the scientific approach is required ( Figure 1 ). We advocate for a new way to conduct science, inspired by the organizational structure, interdisciplinary synergy, and operational excellence of the Manhattan Project (not its goal of developing a weapon). This model will overcome the current fragmentation of the scientific efforts, which are dispersed across tens of thousands of isolated projects, each with distinct objectives, datasets, methodologies, and analyses. It will also not be distracted and disoriented by the current incentive structure in academic research, which focuses on publications. By adopting the collaborative and goal-oriented framework of the Manhattan Project, humanity can refocus the scientific efforts to effectively confront and consign chronic diseases to the annals of history.

The subgingival microbiome has been implicated in oral and systemic diseases such as periodontitis and Alzheimer's disease. However, subgingival sampling is challenging. We developed a novel method of sampling the subgingival microbiome by rotationally swabbing the supragingival area, named subgingival-P (for proxy) samples. We sampled and metatranscriptomically analyzed subgingival and subgingival-P samples of three different teeth in 20 individuals. The subgingival-P samples were comparable to the subgingival samples in the relative abundances of microorganisms and microbial gene expression levels. Our data demonstrate that the novel method of collecting and analyzing the subgingival-P samples can act as a proxy for the subgingiva, paving the way for large and diverse studies investigating the role of the subgingival microbiome in health and disease.

Autism rates have been reported to be increasing rapidly in industrialized societies. The pathology most often combines neurological symptoms associated with language and social impairments with gastrointestinal symptoms. This study aimed to measure differences in oral metatranscriptome and mitochondrial health between ASD children and neurotypical USA and Colombia (“Blue Zone”) children. In addition, this study aimed to determine whether using prebiotics and probiotics would change the oral microbiome and mitochondrial health of ASD children. Buccal swabs and saliva samples were obtained from 30 autistic individuals (USA) at three intervals: prior to intervention, post-prebiotic, and post-probiotic. In addition, a subject component who were neurotypical, which included individuals from the USA (30) and Colombia (30), had buccal swabbing and salivary sampling performed for metatranscriptomic and mitochondrial comparison. Significant differences were observed in the temporal data, demonstrating shifts that interventions with probiotics and polyols may have precipitated. Particular bacterial strains were significantly more prevalent in the autism group, including a strain that reduced neurotransmitter levels via enzymatic degradation. This supports the hypothesis that the microbiome may influence the occurrence and degree of autism. Verbal skills increased in six of the 30 ASD subjects following xylitol and three more after probiotic supplementation, according to both parental reports and the subjects’ healthcare providers.

Autism has been described as a gastrointestinal and neurological condition that is represented by impairments in language and social situations. Recently reported increases in the occurrence of Autism Spectrum Disorder (ASD) have resulted in increased research into the environmental differences between areas with a high occurrence, as in the “Western” diet populations, and a more locally derived diet population, wherein the rate appears to be significantly less. Thirty autistic children (USA) ages 6 to 21, were sampled at three different intervals: prior to any intervention, post-xylitol intervention, and post-probiotic intervention. The sampling consisted of buccal swabs for MITOSWAB testing, and saliva for metatranscriptomics to determine the entire range of microorganisms and the metabolome. In addition, a “Blue Zone” subject component that included 30 Colombian children, ages 6-16, and who were healthy and within normal behavior standards, also had buccal swabbing and salivary sampling performed for comparison along with 30 healthy (no history medications, illnesses, or behavior issues) USA children matched for age and gender. Saliva samples were analyzed metatranscriptomically and artificial intelligence was utilized to discern important differences in the microbiome that included bacteria, archaea, fungi, and viruses, and microbial functions. Significant differences were noted, and seen in the temporal data, demonstrating shifts that may have been precipitated by the interventions, with both the probiotics and the polyols. Particular bacterial strains were significantly more prevalent in the autism subject group including a strain that reduces neurotransmitters by enzymatic degradation. This provided supporting evidence to the hypothesis that the occurrence of autism may also be influenced by low Gamma Amino Butyric Acid (GABA) levels during development. Also, of interest was the un-expected finding that verbal skills dramatically increased in 6 of the 30 ASD subjects following xylitol supplementation.

The authors report here the development of a high-throughput, automated, inexpensive and clinically validated saliva metatranscriptome test that requires less than 100 μl of saliva. RNA is preserved at the time of sample collection, allowing for ambient-temperature transportation and storage for up to 28 days. Critically, the RNA preservative is also able to inactivate pathogenic microorganisms, rendering the samples noninfectious and allowing for safe and easy shipping. Given the unique set of convenience, low cost, safety and technical performance, this saliva metatranscriptomic test can be integrated into longitudinal, global-scale systems biology studies that will lead to an accelerated development of precision medicine, diagnostic and therapeutic tools.

Objective:To investigate the potential association of the gut microbiome with Peyronie’s disease, as there has been no research to date that has studied these topics together. The goal of our study is to better characterize any potential relationships and to discuss possible mechanisms in which they would be related.Methods:Stool samples were collected from 12 participants with Peyronie’s disease and 12 age-matched controls. Metatranscriptome sequencing was used to analyze the samples.Results:No significant differences were found in the gut microbiome characteristics, including Kyoto Encyclopedia of Genes and Genomes richness (p=0.541), Kyoto Encyclopedia of Genes and Genomes diversity (p=0.134), species richness (p=0.933), and species diversity (p=0.597), between the Peyronie’s disease and control group.Conclusions:The results of this study do not support a significant change in the gut microbiome of men with Peyronie’s disease compared to age-matched controls. Further research is needed to fully understand the impact of the gut microbiome on Peyronie’s disease.Trial Registration Number:IRB 2017-3746

Objective: Oral squamous cell carcinoma (OSCC) and oropharyngeal squamous cell carcinoma (OPSCC) can go undetected resulting in late detection and poor outcomes. We describe the development and validation of CancerDetect for Oral & Throat cancerTM (CDOT), to detect markers of OSCC and/or OPSCC within a high-risk population.Material and methods: We collected saliva samples from 1,175 individuals who were 50 years or older, or adults with a tobacco use history. 945 of those were used to train a classifier using machine learning methods, resulting in a salivary microbial and human metatranscriptomic signature. The classifier was then independently validated on the 230 remaining samples prospectively collected and unseen by the classifier, consisting of 20 OSCC (all stages), 76 OPSCC (all stages), and 134 negatives (including 14 pre-malignant).Results: On the validation cohort, the specificity of the CDOT test was 94 %, sensitivity was 90 % for participants with OSCC, and 84.2 % for participants with OPSCC. Similar classification results were observed among people in early stage (stages I & II) vs late stage (stages III & IV).Conclusions: CDOT is a non-invasive test that can be easily administered in dentist offices, primary care centres and specialised cancer clinics for early detection of OPSCC and OSCC. This test, having received FDA's break-through designation for accelerated review, has the potential to enable early diagnosis, saving lives and significantly reducing healthcare expenditure.

BackgroundIrritable bowel syndrome (IBS) is a common gastrointestinal disorder that is thought to involve alterations in the gut microbiome, but robust microbial signatures have been challenging to identify. As prior studies have primarily focused on composition, we hypothesized that multi-omics assessment of microbial function incorporating both metatranscriptomics and metabolomics would further delineate microbial profiles of IBS and its subtypes.MethodsFecal samples were collected from a racially/ethnically diverse cohort of 495 subjects, including 318 IBS patients and 177 healthy controls, for analysis by 16S rRNA gene sequencing (n = 486), metatranscriptomics (n = 327), and untargeted metabolomics (n = 368). Differentially abundant microbes, predicted genes, transcripts, and metabolites in IBS were identified by multivariate models incorporating age, sex, race/ethnicity, BMI, diet, and HAD-Anxiety. Inter-omic functional relationships were assessed by transcript/gene ratios and microbial metabolic modeling. Differential features were used to construct random forests classifiers.ResultsIBS was associated with global alterations in microbiome composition by 16S rRNA sequencing and metatranscriptomics, and in microbiome function by predicted metagenomics, metatranscriptomics, and metabolomics. After adjusting for age, sex, race/ethnicity, BMI, diet, and anxiety, IBS was associated with differential abundance of bacterial taxa such as Bacteroides dorei; metabolites including increased tyramine and decreased gentisate and hydrocinnamate; and transcripts related to fructooligosaccharide and polyol utilization. IBS further showed transcriptional upregulation of enzymes involved in fructose and glucan metabolism as well as the succinate pathway of carbohydrate fermentation. A multi-omics classifier for IBS had significantly higher accuracy (AUC 0.82) than classifiers using individual datasets. Diarrhea-predominant IBS (IBS-D) demonstrated shifts in the metatranscriptome and metabolome including increased bile acids, polyamines, succinate pathway intermediates (malate, fumarate), and transcripts involved in fructose, mannose, and polyol metabolism compared to constipation-predominant IBS (IBS-C). A classifier incorporating metabolites and gene-normalized transcripts differentiated IBS-D from IBS-C with high accuracy (AUC 0.86).ConclusionsIBS is characterized by a multi-omics microbial signature indicating increased capacity to utilize fermentable carbohydrates-consistent with the clinical benefit of diets restricting this energy source-that also includes multiple previously unrecognized metabolites and metabolic pathways. These findings support the need for integrative assessment of microbial function to investigate the microbiome in IBS and identify novel microbiome-related therapeutic targets.

Recent studies have identified microbial components in most tumors and invoked microorganisms in cancer onset and progression. The microbial functions responsible for these effects likely include production of genotoxins, modification of human gene expression, and protection of cancer cells from immune surveillance. Metatranscriptomics (MT) is a powerful tool for the development of potential cancer diagnostics and therapeutics, as well as investigating cancer initiation and progression. This is because MT data can quantify human and microbial gene expression, as well as provide strain level taxonomic classification of the microorganisms in the tumor microenvironment (TME). In addition, the microbial data derived from the MT method can easily be normalized across different samples, since many human transcripts can act as internal standards. When collecting tissue samples for clinical studies, researchers have the option of using fresh or Formalin-Fixed Paraffin-Embedded (FFPE) samples. FFPE samples are much easier to study, due to their widespread availability and ease of collection, storage, and handling. Little research exists comparing FFPE samples and fresh tissues, and there is no literature examining the differences in microbial signatures between these two sample preservation methods. In this study, we analyzed matched FFPE samples and fresh tissue samples from colon polyps of 13 participants for microbial and human components. We found that our clinically validated MT method generated equivalent data from FFPE samples and fresh tissue samples with high concordance for human gene expression (Pearson 0.70), microbial species (Pearson 0.94), and KEGG Orthologs (Pearson 0.97). These data indicate that FFPE samples are suitable for use in metatranscriptomic analyses, which will enable more diverse and larger oncology studies, as well as any other studies that benefit from MT analysis of tissue samples.

Accurate measurement of the biological markers of the aging process could provide an "aging clock" measuring predicted longevity and enable the quantification of the effects of specific lifestyle choices on healthy aging. Using machine learning techniques, we demonstrate that chronological age can be predicted accurately from (1) the expression level of human genes in capillary blood and (2) the expression level of microbial genes in stool samples. The latter uses a very large metatranscriptomic dataset, stool samples from 90,303 individuals, which arguably results in a higher quality microbiome-aging model than prior work. Our analysis suggests associations between biological age and lifestyle/health factors, e.g., people on a paleo diet or with IBS tend to have higher model-predicted ages and people on a vegetarian diet tend to have lower model-predicted ages. We delineate the key pathways of systems-level biological decline based on the age-specific features of our model.

Many studies have shown that foods and nutritional ingredients play an important role in healthy human homeostasis, either directly or via the microbiome. We have developed an objective, integrated, and automated approach to personalized food and supplement recommendations that is powered by artificial intelligence and individualized molecular data from the gut microbiome, the human host, and their interactions. The process starts with a clinically validated transcriptomic analysis of a person's stool (and some cases also blood) sample. These molecular data are converted into personalized nutritional recommendations (foods and supplements) using algorithms derived from clinical research studies and domain knowledge. We describe an application of our precision nutrition technology platform to human populations with irritable bowel syndrome (IBS), depression, anxiety, and type 2 diabetes (T2D). In these pilot interventional studies, our precision nutrition program achieved significant improvements in clinical outcomes of IBS (39% for severe IBS), depression (31% for severe depression), anxiety (31% for severe anxiety), and the risk score for T2D (>30% reduction relative to the control arm). These data support the integration of data-driven precision nutrition into the standard of care.

BACKGROUND:To-date there have been minimal studies to investigate an association between the gut microbiome and erectile dysfunction. There have been many inflammatory diseases linked to gut microbiome dysbiosis; such as cardiovascular disease and metabolic syndrome. These same inflammatory diseases have been heavily linked to erectile dysfunction. Given the correlations between both conditions and cardiovascular disease and the metabolic syndrome, we believe that it is worthwhile to investigate a link between the two. OBJECTIVE:To investigate the potential association between the gut microbiome and erectile dysfunction. METHODS:Stool samples were collected from 28 participants with erectile dysfunction and 32 age-matched controls. Metatranscriptome sequencing was used to analyze the samples. RESULTS:No significant differences were found in the gut microbiome characteristics, including Kyoto Encyclopedia of Genes and Genomes richness (p = 0.117), Kyoto Encyclopedia of Genes and Genomes diversity (p = 0.323), species richness (p = 0.364), and species diversity (p = 0.300), between the erectile dysfunction and control groups. DISCUSSION:The association of gut microbiome dysbiosis and pro-inflammatory conditions has been well studied and further literature continues to add to this evidence. Our main limitation for this study was our small-sample size due to recruitment issues. We believe that a study with a larger population size may find an association between the gut microbiome and erectile dysfunction. CONCLUSIONS:The results of this study do not support a significant association between the gut microbiome and erectile dysfunction. Further research is needed to fully understand the relationship between these two conditions.

Objective Infectious diseases are common but are not easily or readily diagnosed with current methodologies. This problem is further exacerbated with the constant presence of mutated, emerging, and novel pathogens. One of the most common sites of infection by many pathogens is the human throat. Yet, there is no universal diagnostic test that can distinguish these pathogens. Metatranscriptomic (MT) analysis of the throat represents an important and novel development in infectious disease detection and characterization, as it is able to identify all pathogens in a fully unbiased approach. Design To test the utility of an MT approach to pathogen detection, throat samples were collected from participants before, during, and after an acute sickness. Results Clear sickness-associated shifts in pathogenic microorganisms are detected in the participants along with important insights into microbial functions and antimicrobial resistance genes. Conclusions MT analysis of the throat represents an effective method for the unbiased identification and characterization of pathogens. Since MT data include all microorganisms in the sample, this approach should allow for not only the identification of pathogens, but also an understanding of the effects of the resident throat microbiome in the context of human health and disease.

You have accessJournal of UrologySexual Function/Dysfunction: Basic Research & Pathophysiology (PD62)1 Sep 2021PD62-08 DIFFERENCES IN THE GUT MICROBIOME COMPOSITION BETWEEN MEN WITH ERECTILE DYSFUNCTION AND A MATCHED COHORT: A PILOT STUDY Mahdi Osman, Farouk El-Khatib, Jeanie Nguyen, Edward Choi, Joshua Randolph, Guruduth Banavar, Ying Cai, Pedro Moura, Nan Shen, Ryan Toma, Momchilo Vuyisich, Nathalie Yafi, and Faysal Yafi Mahdi OsmanMahdi Osman More articles by this author , Farouk El-KhatibFarouk El-Khatib More articles by this author , Jeanie NguyenJeanie Nguyen More articles by this author , Edward ChoiEdward Choi More articles by this author , Joshua RandolphJoshua Randolph More articles by this author , Guruduth BanavarGuruduth Banavar More articles by this author , Ying CaiYing Cai More articles by this author , Pedro MouraPedro Moura More articles by this author , Nan ShenNan Shen More articles by this author , Ryan TomaRyan Toma More articles by this author , Momchilo VuyisichMomchilo Vuyisich More articles by this author , Nathalie YafiNathalie Yafi More articles by this author , and Faysal YafiFaysal Yafi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002099.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The gut microbiome (GM) plays an important role in human health, ranging from supplying essential nutrients, synthesizing vitamin K, to promoting angiogenesis and enteric nerve function. It has also been recently associated with a variety of chronic health conditions. To date, however, there have been no studies that have attempted to establish any association between the GM and erectile dysfunction (ED). As such, we sought to analyze stool samples from patients with ED and compare them to matched controls for differences in their GM. METHODS: We collected stool samples from 37 patients with ED and matched them with 37 controls. All samples were processed by a third-party company, Viome Inc. The samples were analyzed by metatranscriptome sequencing which allows for data to show both the taxonomy of the microbiome and its KEGG orthology (KO). We compared richness, prevalence and expression of the taxa and KOs between the ED and control groups. RESULTS: There were 224 species (16.85%) with significantly differential prevalence and 135 species (10.31%) with significantly differential expression. There were 565 KOs (10.42%) with significantly differential prevalence and 653 KOs (12.05%) with significantly differential expression. Richness is the number of microbial species detected in a sample. Diversity assesses the abundance and evenness of a species to assess how diverse an individual sample is. The ED group demonstrated significantly lower taxonomic richness and diversity, p= 1.33 x 10^-5 (see figure below). CONCLUSIONS: This is the first study to look at associations between the GM and ED. Patients with ED have significantly lower taxonomic richness and diversity. Further analyses are needed to better understand the implications of these findings and uncover potential targets for early targeted treatment or prevention of ED. Source of Funding: microbiome analysis kits were provided by Viome, Inc © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1075-e1075 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mahdi Osman More articles by this author Farouk El-Khatib More articles by this author Jeanie Nguyen More articles by this author Edward Choi More articles by this author Joshua Randolph More articles by this author Guruduth Banavar More articles by this author Ying Cai More articles by this author Pedro Moura More articles by this author Nan Shen More articles by this author Ryan Toma More articles by this author Momchilo Vuyisich More articles by this author Nathalie Yafi More articles by this author Faysal Yafi More articles by this author Expand All Advertisement Loading ...

Background Current dietary recommendations are often generalized, conflicting, and highly subjective, depending on the source biases. This results in confusion, skepticism, and frustration in the general population. Methods We have developed an objective, integrated, automated, algorithmic approach to diet and supplement recommendations that is powered by artificial intelligence that analyzes individualized molecular data from the gut microbiome, the human host, and their interactions. This platform enables precise, personalized, and data-driven nutritional recommendations that consist of foods and supplements, based on the individual molecular data, to establish and maintain healthy homeostasis. Results We describe the application of our precision nutrition technology platform to populations with depression, anxiety, irritable bowel syndrome (IBS), and type 2 diabetes (T2D). In a blinded interventional study, we provided the study participants with precision nutritional recommendations and observed improvements in clinical outcomes by 36% in severe cases of depression, 40% in severe cases of anxiety, 38% in severe cases of IBS, and more than 30% in the T2D risk score that was validated against clinical measurements of HbA1c. Conclusion Our AI-driven precision nutrition program achieved statistically significant improvements in clinical outcomes of depression, anxiety, IBS, and type 2 diabetes. These data support the integration of precision food and supplements into the standard of care for these chronic conditions.