product_ibsure

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IBSSure

A simple and reliable tool for detecting IBS-D associated with Small Intestinal Bacterial Overgrowth (SIBO)

IBS is a commonly occurring collection of symptoms diagnosed in the world of gastroenterology. It is the most common GI disorder with worldwide prevalence rates ranging from 10-15%. There are between 2.4 and 3.5 million physician visits annually for IBS in the US. Recent research has shown that up to 84% of those with an IBS diagnosis test positive for a Small Intestinal Bacterial Overgrowth breath test.

Breath tests for Small Intestinal Bacterial Overgrowth can be very time consuming for patients, as well as inaccurate, due to many factors.

IBSSureTM is a simple blood test that detects two antibodies which are indicative of bacterial-pathogen-induced motility dysfunction, which can lead to increased incidence of SIBO.
CdtB toxins (cytolethal distending toxin B) are released by gastroenteritis-causing bacteria, against which antibodies are produced by the immune system. These antibodies interact with a protein, vinculin, present in the intestinal cell-lining matrix. This interaction compromises and impairs digestive motility. This pathological breakdown of the gastrointestinal motility complex is foundational to chronic SIBO development and recurrence and has been well-studied and documented.

Not Available in New York state
Only healthcare providers licensed in their state may order laboratory testing.

*Vibrant Wellness does not participate in, take assignment, or accept any private insurance. We do not provide super bills and cannot assist with claim resolution for laboratory tests or consultations.

  • Anti-CdtB IgG and IgA
  • Anti-vinculin IgG and IgA

WHAT IS SIBO?

  • Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excessive bacteria in the small intestine
  • SIBO is frequently implicated as the cause of chronic diarrhea and malabsorption in addition to intestinal hyper-permeability
  • Patients with SIBO may also suffer from unintentional weight loss, nutritional deficiencies, and osteoporosis
  • A common misconception is that SIBO affects only a limited number of patients, such as those with an anatomic abnormality of the upper gastrointestinal (GI) tract or those with a motility disorder
  • SIBO may be more prevalent than previously thought. This apparent increase in prevalence may have occurred, in part, because readily available diagnostic tests have improved our ability to diagnose SIBO

Symptoms associated with SIBO

  • Abdominal pain/discomfort
  • Bloating
  • Abdominal distension
  • Diarrhea
  • Excessive gas
  • Fatigue, especially after meals
  • Brain fog
  • Vitamin and mineral deficiencies
  • Worsened symptoms when consuming carbohydrates and fibrous vegetables
  • Unexplained weight loss

If this test is negative but I still have the symptoms, is it possible that I might still have SIBO?

IBSSureTM measures two blood-based antibodies that can be used in the diagnostic workup of IBS, and to rule out IBD. These antibodies can also identify past exposure to bacterial toxin (food poisoning), and autoimmunity of the intestinal motility system (pacemaker cells in the GI tract). Finally, anti-CdtB antibody has been correlated with positive SIBO diagnosis. It is still possible to have the signs and symptoms of SIBO without having a positive result on this test.

If this test is capturing an infectious gastroenteritis event, how many years back would the event be accounted for?

A systematic review and meta-analysis found that more than 10% of individuals with infectious enteritis later develop IBS. The overall risk of developing IBS is 4.2 times higher in individuals with a history of infectious enteritis versus individuals without a history of infectious enteritis. The prevalence of IBS at 12 months after infectious enteritis was 10.1% and at more than 12 months after infectious enteritis was 14.5%. Studies have examined post-infectious IBS onset within 12 months, within 13-59 months, and greater than 60 months (5 years) after the infectious event. Prevalence of post-infectious IBS depends upon the pathogen(s) involved, geographic location, clinically suspected or laboratory-proven enteritis, time of medical assessment following the infectious enteritis, and the criteria used to define IBS. Some studies report a decline in prevalence of IBS over time since the infectious event, whereas others report an increase in prevalence of IBS over time since the infectious event. It is unknown how long CdtB antibodies and vinculin antibodies will persist after an infectious enteritis.

Does positive anti-vinculin indicate an autoimmune condition?

Yes, because the body is producing antibodies to the vinculin protein located in the migrating motor complex (MMC), therefore, antibodies to its own tissues.

What does IBS-M mean?

IBS-M means Irritable Bowel Syndrome – Mixed, which means the patient experiences a combination of constipation and diarrhea.

I was told that this is not a SIBO test. What is IBSSure testing?

Vibrant’s IBSSureTM is a simple, gut-motility test that can be used to identify irritable bowel syndrome (IBS), and to rule out inflammatory bowel disease (IBD). We identify two markers: CdtB (Cytolethal Distending Toxin B) and anti-vinculin, which confirms dysmotility at the junction of the large and small intestine; this could present itself symptomatically as diarrhea or constipation. The importance of understanding the migrating motor complex (MMC) can help alleviate your patient’s symptoms. Should both biomarkers be elevated, there is an 89% correlation to SIBO. Simple intervention of a prokinetic supplementation and lifestyle changes that will stimulate the MMC could provide your patient with symptomatic alleviation.

References

Lin, Henry C. “Small Intestinal Bacterial Overgrowth: A Framework for Understanding Irritable Bowel Syndrome.” Jama 292.7 (2004): 852. Web.

Pimentel Mark, Walter Morales, Ali Rezaie, Emily Marsh, Anthony Lembo, James Mirocha, Daniel

A.Leffler, Zachary Marsh, Stacy Weitsman, Kathleen S. Chua, Gillian M. Barlow, Enoch Bortey,

William Forbes, Allen Yu, and Christopher Chang. “Development and Validation of a Biomarker for

Diarrhea-Predominant Irritable Bowel Syndrome in Human Subjects.” PLOS ONE PLoS ONE 10.5 (2015): n.

pag. Web.

Pimentel Mark, Walter Morales, Venkata Pokkunuri, ConstantinosBrikos, Sun Moon Kim, SeongEun

Kim, Konstantinos Triantafyllou, Stacy Weitsman, Zachary Marsh, Emily Marsh, Kathleen S. Chua,

Shanthi Srinivasan, Gillian M. Barlow, and Christopher Chang. “Autoimmunity Links Vinculin to the

Pathophysiology of Chronic Functional Bowel Changes Following Campylobacter Jejuni Infection in a

Rat Model.” Dig Dis Sci Digestive Diseases and Sciences 60.5 (2014): 1195-205. Web.

Pimentel Mark, Walter Morales, Ali Rezaie, Emily Marsh, Anthony Lembo, Daniel A.Leffler, Stacy

Weitsman, Kathleen S. Chua, Gillian M. Barlow, Enoch Bortey. ” Assessment of Anti- vinculin and

Anti-cytolethal Distending Toxin B Antibodies in Subtypes of Irritable BowelSyndrome.” Dig Dis Sci: Digestive Disease and Science. 62.6 (2017)

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Regulatory Statement

Vibrant testing does not demonstrate absolute positive and negative predictive values for any disease state or condition. Its clinical utility has not been fully established. Vibrant validates the accuracy and precision of the testing but not of its clinical or diagnostic value. So these tests are for wellness and informational purpose only. Vibrant is actively doing clinical research on these samples, de-identified from patients under an IRB and will make research publications towards the same as and when the clinical utility is well established. These tests have been laboratory developed and their performance characteristics determined by Vibrant America LLC, a CLIA-certified laboratory performing the test CLIA#:05D2078809. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. The general wellness test intended uses relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions. Content provided for informational purposes only and should not be construed as medical advice. Content provided to help you make a healthy lifestyle, dietary, and treatment choices in consultation with your healthcare provider. It is intended to be used as a tool to encourage a general state of health and well-being. Please consult with your healthcare practitioner for diagnosis and treatment considerations. The Vibrant Wellness platform provides tools for you to track and analyze your general wellness profile.