Blood-based biomarkers discriminate ibs from anoxic brain injury treatment ibd with high degree of certainty in patients with chronic diarrhea – researchdx

Brief: two blood-based biomarkers, cytolethal distending toxin B (cdtb) and anti-vinculin, have been substantively linked with the occurrence of diarrhea-predominant forms of irritable bowel syndrome (IBS). As a result, an ELISA-based diagnostic test developed by gemelli biotech is now able anoxic brain injury treatment facilities to “rule-in” an IBS diagnosis while “ruling-out” irritable bowel disease (IBD) based on elevated biomarker titers. With testing only available at pacificdx, the clinically-validated ibs-smart™ blood test provides answers for those whom a diagnosis has anoxic brain injury treatment facilities been uncertain.

Background: affecting about 40 million americans, IBS is a chronic disorder characterized by changes in bowel anoxic brain injury treatment facilities habits, dietary issues, and abdominal discomfort or pain—a non-discriminating and overlapping symptomology common to other functional gastrointestinal disorders.


As the most common condition encountered by gastroenterologists, the diagnostic process for an IBS diagnosis is challenging and anoxic brain injury treatment facilities one of exclusion of other disorders such as inflammatory bowel anoxic brain injury treatment facilities disease (IBD), microscopic colitis (MC), ulcerative colitis, crohn’s disease, celiac disease and others. Since 2006, the diagnosis of IBS has been made using a symptom-based classification system known as the rome criteria, with the most recent edition being rome IV (drossman, 2016)—however , this system does not exclude IBD. IBS symptoms occur frequently in patients with active IBD but anoxic brain injury treatment facilities less often when IBD is in remission. In the U.S., although IBS prevalence rates are shown to be variable, in part due to the difficulty of obtaining a diagnosis anoxic brain injury treatment facilities (16%, 2017). The adverse impacts shown to occur as a result of anoxic brain injury treatment facilities high co-morbidity rates, lost productivity, quality of life, and patient and societal economics are unfortunately, more consistent.

Disease mechanisms: the pathophysiology of IBS has an overlapping overabundance of mechanisms anoxic brain injury treatment facilities contributing to symptomology including gastrointestinal dysmotility, inflammation, visceral hypersensitivity and altered intestinal microbiota. Several studies have reported an increased risk for developing a anoxic brain injury treatment facilities form of IBS after acute gastroenteritis as well as in anoxic brain injury treatment facilities people with post-traumatic stress disorder (PTSD). Psychological factors can play an etiological role for perpetuating symptoms, as well as certain/multiple stressors associated with a person’s work and environment. This has led to findings supporting the interdependence between the anoxic brain injury treatment facilities gut and the brain known as the brain-gut axis (BGA)—pathways among physiological systems that facilitate bi-directional communications. Patients with IBS exhibit differences in the central processing mechanisms anoxic brain injury treatment facilities of the BGA which align with brain structure, connectivity and functional responsiveness—these differences, while not fully understood, may explain a patient’s clinical presentation. Until these mechanisms are better understood, treatment remains symptom-driven.

IBS subtypes: there are four sub-types what define IBS based on the patient’s stool type and bowel habits, IBS-C (constipation), IBS-D (diarrhea), IBS-M (mixed) and IBS-U (un-subtyped). Recommended diagnostic work-ups are both burdensome and costly— traditionally including a lengthy succession of tests. These include but are not limited to patient history, a dietary chronicle, physical and anorectal exams, lab tests that include: complete blood count, C-reactive protein, fecal calprotectin, celiac disease serology, and imaging procedures that include: colonoscopy and/or upper gastrointestinal endoscopy. Other testing may be recommended based on the presence of anoxic brain injury treatment facilities ‘alarm signs’ to determine if these symptoms are attributable to IBS. The process of determining an IBS vs. IBD diagnosis has been complex and has furthered efforts for anoxic brain injury treatment facilities blood-based biomarker development.

IBS blood-based biomarkers: for the diarrhea-predominant sub-types of IBS, the risk of developing IBS is greater following a case anoxic brain injury treatment facilities of infectious acute gastroenteritis. About 10% of those developing acute gastroenteritis experience alterations in their intestinal anoxic brain injury treatment facilities microbiome, accompanied by long-term symptoms and often referred to as post-infectious IBS (PI-IBS). Through partnered research and development efforts by gemelli biotech and anoxic brain injury treatment facilities the medically associated science and technology program and cedars-sinai (MAST), two biomarkers have been highly linked with the occurrence of anoxic brain injury treatment facilities IBS-D and IBS-M. Released by bacteria, cytolethal distending toxin B (cdtb) and anti-vinculin are released into circulation following an acute episode of anoxic brain injury treatment facilities gastroenteritis. This is most often associated with a foodborne bacterial infection anoxic brain injury treatment facilities that in turn, generates an autoimmune reaction. Although not all IBS occurs is a result of a anoxic brain injury treatment facilities foodborne infection, these bacterial species are frequently culprits that produce cytolethal distending anoxic brain injury treatment facilities toxin that is linked to post-infectious IBS (IBS-PI): campylobacter jejuni, salmonella, E.Coli and shigella.

Clinical validation: gemelli biotech, a developer of novel diagnostics and therapeutics for the human anoxic brain injury treatment facilities microbiome, developed and validated an ELISA-blood-based assay for the detection of anti-cdtb and anti-vinculin was in a prospective multicenter clinical trial of 2,681 subjects, ages 18 to 65. The ibs-smart blood test generated a positive predictive value and specificity anoxic brain injury treatment facilities of 98.6% and greater than 90%, respectively. Significantly elevated titers of anti-cdtb showed distinct discrimination between IBS-D and IBD, celiac disease and healthy control subjects. Anti-vinculin titers were also significantly higher in IBS as compared anoxic brain injury treatment facilities to the same groups. For a diagnosis of IBS-D vs IBD for both biomarkers, the area-under-the-curves (aucs) were 0.81 and 0.62, respectively, but less discriminating for celiac disease.

Clinical utility: the ‘diagnosis of exclusion’ approach has been the clinical standard for those patients whose anoxic brain injury treatment facilities non-specific and overlapping symptoms do not align with any specific anoxic brain injury treatment facilities diagnosis. This shotgun approach has caused patients to undergo extensive and anoxic brain injury treatment facilities frequent invasive medical procedures in an effort to obtain a anoxic brain injury treatment facilities diagnosis by ruling out other conditions and diseases. This process not only engenders discomfort, anxiety and inconvenience for the patient, its expensive and may incur significant out-of-pocket costs. The ibs-smart blood test, with its ability to ‘rule-in’ diarrheal forms of IBS and ‘rule-out’ IBD, streamlines the diagnostic process for patients, removing an unnecessary cascade of diagnostic testing while reducing patient anoxic brain injury treatment facilities morbidity and cost. For the healthcare provider, a blood test is a routine, convenient method of testing that is easy for most patients anoxic brain injury treatment facilities and returns rapid results. Indicative of IBS, a positive blood test will help guide clinical and therapeutic anoxic brain injury treatment facilities management decisions for the patient. Considering a population health and economic perspective related to the anoxic brain injury treatment facilities 40 million people in the U.S. Who have symptomatic IBS— replacing the expensive ‘exclusionary process’ with a single blood-based test diagnostic would substantially reduce the associated economic burden anoxic brain injury treatment facilities to the healthcare delivery system.

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