IBdoc Home test

Home test finds gut inflammation before relapse (3 months prior)

SUMMARY:  Imagine a home test differentiating between Irritable Bowel Syndrome (IBS) and autoimmune Inflammatory Bowel Disease (IBD)! The time is nearing…  IBdoc is a cheap easy to use home test that measures gut inflammation and presently is used in Europe.  It is still 2 to 3 years away from FDA approval in the US, but clinical trial recruitment has begun; make the call and participate (see below for details.) The device finds gut inflammation before relapse or flare: actually 3 months ahead of IBD relapse giving you (and your physician) time to address such.  The device hopefully too will be found capable of differentiating between IBD versus IBS.  Update: tweeted from 11th Congress of ECCO March 16-19, 2016 presentation: fecal calprotectin rises 4 months before flares. 

This is a game changer and profoundly changes how IBD can be managed targeting better for those most in need, including pediatric population, endoscopy as well as colonoscopy.
This science taps into Smartphones and the future of inflammatory markers… you know it is coming, and I am grateful for this!
Home test finds gut inflammation before relapse, actually 3 months before relapse

According to the article, Colitis Monitoring May Soon Start at Home Like diabetics check their blood sugar, IBD patients will test for inflammation, the device measures gut inflammation that would :

  1. Differentiate between IBS versus IBD diagnostic workup in patients presenting with diarrhea, and
  2. Predict 3 months ahead of UC relapse thus giving patients and physicians’ time to better address gut inflammation to avoid the relapse. (J Crohns Colitis 2015;9:1-3)  

lightbulb2My hope is that this motivation allows these patients to address anti-inflammatory dietary management to preclude relapse.  See the posts:

At Home Testing Could Improve IBD Outcomes since inflammation is found months before relapse

Precedent already in fact exists for this consideration (glucose monitoring for diabetes.)  I think that an at-home test that can allow us to tightly control [gut] inflammation the way that endocrinologists aim to tightly control glucose levels in diabetic patients…has the potential to improve IBD outcomes… and is the right thing to do.” -Peter Higgins, MD, director of the IBD program at the University of Michigan, Ann Arbor, Colitis Monitoring May Soon Start at Home Like diabetics check their blood sugar, IBD patients will test for inflammation, who has no financial interest in the device.

Fecal calprotectin levels rise ~3 months prior to disease exacerbation

Consequently, IBdoc at home testing would be performed every 3 months per BÜHLMANN recommendations. The device is easy to use, and calprotectin levels using the device correlated well with endoscopically confirmed mucosal inflammation (A new rapid quantitative test for fecal calprotectin predicts endoscopic activity in ulcerative colitis, Inflamm Bowel Dis 2013;19:1034-1042).

See the Instructional YouTube:  IBDoc® Calprotectin Home Testing from BÜHLMANN

To participate in the clinical trials:

BüHLMANN Laboratories US clinical trials link: BÜHLMANN fCAL™ ELISA – Aid in Differentiation of IBD From IBS, ClinicalTrials.gov Identifier: NCT02351635, Contacts and Locations: Stanford CA, Miami FLA, Urbana IL, Chevy Chase Maryland, Kingsport TN, and Chesapeake VA.  Note: you may not need to be located by these participating sites; make calls and see if they’ll liaison with you and your physician.

embellishment7Please consider participating in the IBdoc clinical trials; it costs you nothing but will better lives of millions!
And… it could alert you 3 months ahead of IBD relapse, at a time you can actively do something about diet to be anti-inflammatory thereby reducing gut inflammation and hopefully avoiding relapse.
Please pass this post on so that others can participate too!embellishment7
Three easy steps to performing the home test
  1. Extract sample and run test

    Fast and simple sample collection and test cassette loading with the CALEX® Valve extraction device.

  2. Take picture

    CalApp® turns your smartphone into an easy to use test cassette reader.

  3. Automatic communication
    to IBD center

    The CalApp® transmits new test results securely to your doctor.

Not surprising… the IBDoc test costs much less ($45 vs $200) and has a much faster test result turnaround (12 minutes instead of 10 days) compared to that now available in the US

The IBDoc test costs $45 with results available in 12 minutes; this is way below the $200 price tag (and 10 day wait for test results) for fecal calprotectin tests currently approved in the US: Genova Diagnostics’ Calprotectin PhiCal ELISA and Inova Diagnostics’ QUANTA Lite Calprotectin.

Supporting Data for IBdoc®
  1. A study of 146 patients with ulcerative colitis showed calprotectin levels that were measured using a technology identical to that in the IBDoc, and
  2. A trial of 25 healthy volunteers presented at the 2015 annual congress of the European Crohn’s and Colitis Organization (abstract A-1621) demonstrated that the device is user-friendly, with almost all participants performing the test successfully after one training session and 21 individuals saying they felt comfortable using a smartphone for medical testing.
caution sign3IBdoc and colon cancer. One goal of the IBdoc clicnical trial is to show ability to differentiate IBD from IBS; such could trigger further investigation helping to find early colon cancer which is increasing especially in those under age 50 years

The post, YOUNG ADULT NEWLY DIAGNOSED COLON & RECTAL CANCER (CRC) DOUBLES BY 2030, noted that researchers are warning physicians to be on the lookout for CRC symptoms that might otherwise be dismissed in younger people and only identified as cancer after the disease has progressed since CRC is not on the radar. The trends are discussed in this “Science Daily” article which is based on this study, which astonishingly noted:  the number of young adults (aged 20 to 34, and 35 to 49 years) with newly diagnosed colorectal cancer is anticipated to nearly double by 2030:

  • For ages 20 to 34 years, colon cancer increase is 90.0% and rectal cancer increase is 124.2% by the year 2030.
  • For ages 35 to 49 years, colon cancer increase is 27.7% and rectal cancer increase is 46.0% by the year 2030.

For patients under age 34, the increase is across all stages of disease: localized (confined to the colon or rectum), regional (contiguous and adjacent organ spread, such as to the lymph nodes, kidney and pelvic wall) and distant (referring to remote metastases).  The chart and graph below (young adult cancer increases are circled) shows the estimated increases:

While IBS is not currently associated with CRC at this time, CRC is part of the IBS differential  diagnosis

IBS affects up to 15% of the general adult population.  Studies to date (here, and here) have not found an association between IBS and CRC.  Young aged patients may be handed an IBS diagnosis when it may really be the beginning of CRC given that the number of young adults (aged 20 to 34, and 35 to 49 years) with newly diagnosed CRC is anticipated to nearly double by 2030. 

Both IBS and CRC have altered gut microbiome: for CRC see this study, “The Gut Microbiome Modulates Colon Tumorigenesis”  dated November, 2013.  For IBS see this paper, “Irritable bowel syndrome, inflammatory bowel disease and the microbiome dated February 2014 which notes:

“Gene polymorphisms associated with inflammatory bowel disease increasingly suggest that interaction with the microbiota drives pathogenesis. This may be through modulation of the immune response, mucosal permeability or the products of microbial metabolism. Similar findings in irritable bowel syndrome have reinforced the role of gut-specific factors in this ‘functional’ disorder. Metagenomic analysis has identified alterations in pathways and interactions with the ecosystem of the microbiome that may not be recognized by taxonomic description alone, particularly in carbohydrate metabolism. Treatments targeted at the microbial stimulus with antibiotics, probiotics or prebiotics have all progressed in the past year. Studies on the long-term effects of treatment on the microbiome suggest that dietary intervention may be needed for prolonged efficacy.”

IBdoc should be helpful in the IBS/IBD/CRC differential diagnostic workup. If IBS, try the FODMAPS dietary intervention and possibly avoid IBS medications.

If gut inflammation is confirmed as IBS, dietary management is possible using FODMAPS intervention, which has over 74% success for IBS patients, as noted in the paper, “Fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) and nonallergic food intolerance: FODMAPs or food chemicals?” dated July 2012.  The evidence and application of the most common approaches to managing food intolerance in IBS were the low-FODMAP diet, the elimination diet for food chemical sensitivity and others including possible noncoeliac gluten intolerance), concluding:

“…considerable evidence supporting the low-FODMAP diet for IBS, and the fact that it is relatively easy to implement without significant nutritional concerns, supports the suggestion that this should be the first dietary manipulation trialled in patients presenting with IBS. “

Surprisingly and sadly, the Nov. 2014 Medical News Today article, “Managing IBS effectively with the right drugs, for the right symptoms” listed new IBS prescription guidelines and accompanying technical review as published in Gastroenterology, the official journal of the American Gastroenterological Association, which seemingly dismiss FODMAP dietary protocol for IBS despite it’s published success. The new guidelines noted:

“Gluten-free and low-FODMAP diets show promise but their precise role(s) in the management of IBS need to be defined… Role of dietary manipulation in IBS: Specialized diets may improve symptoms in individual IBS patients.  Recommendation: weak. Quality of evidence: very low.  A significant limitation of this study was the lack of blinding regarding the dietary intervention.”  NOTE:  There actually is quite a lot of literature supporting the use of FODMAPs for IBS, see the post, IBS: FODMAPS, STOMACH MICROBIOME & RIFAXIMIN ANTIBIOTIC TREATMENT, SERIOUSLY?!?

Most Important: IBS patients may successfully modify diet using FODMAPs and avoid the new guideline prescription medications

It is totally interesting that recent science is now publishing many studies (just goggle) linking the gut/brain axis and microbiome link to influencing mood, thought, anxiety, depression, autism  How IBS and CRC tie together, if at all, is yet to be determined but modifying diet (with the specific FODMAPS protocol now known for IBS) are recommendations for both IBS and gut/brain issues. It would be great to avoid the medications being used for IBS and brain issues; those used for IBS incredibly are:

  • Patients w/IBS-C: linaclotide, lubiprostone,  Patients w/IBS-D: rifaximin,alosetron, loperamide.
  • Addtionally, recommendations include for patients w/IBS: tricyclic antidepressants, selective serotonin reuptake inhibitors, and antispasmodics.
embellishment7In conclusion and bears repeating:  Please consider participating in the IBdoc clinical trials; it costs you nothing but will better lives of millions!
And… it could alert you 3 months ahead of IBD relapse, at a time you can actively do something about diet to be anti-inflammatory thereby reducing gut inflammation and hopefully avoiding relapse.
Please pass this post on so that others can participate too!embellishment7

Other Relevant Publications (update from original posting):

Updated to add Biomarkers as potential treatment targets in inflammatory bowel disease: A systematic review, 2015 link.  Last updated: July 4, 2016 at 10:58 am   Prior update added tweet from 11th Congress of ECCO March 16-19, 2016 presentation: fecal calprotectin rises 4 months before flares. Also updated for SEO optimization.

In health through awareness,

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