Summary: Do yourself a favor and look over this post about gut microbiome manipulation even if your interest in microbiome is not autism or Fecal Microbiota Transplant (FMT) because the microbiome can be manipulated many ways, FMT being only one way. DIET has a major impact on microbiome, and I’m surprised that there are only three clinical trials looking at diet and autism out of the 445 clinical trials looking at diet and microbiome (as of May 28, 2019). More surprising, there’s nearly300 clinical trailsnow going on that look at FMT impact to the microbiome for many of the diseases you guys have, like: IBS, T2D, MS, IBD, melanoma, cancer, depression, anxiety, obesity, metabolic syndrome, liver NAFLD, Alzheimer’s, Parkinson’s, Psoriatic Arthritis, food allergies, recurrent UTIs, Sarcoidosis, antibiotic resistance, Chronic Fatigue Syndrome, epilepsy, Sjogren’s, HIV, malnutrition…. Manipulation of the microbiome is being looked at because the microbiome is known to be altered in inflammatory ways for most all diseases, and it’s health determines your health. For autism for example, [Saghazadeh et al 2019] reported an increase in pro-inflammatory cytokines called IFN-γ, IL-1β, IL-6, and TNF-α. That’s the immune system gone rogue. Here’s the laundry list of pro-inflammatory cytokines that were found to have no significant alteration: IL-1α, IL-2, IL-2R, IL-3, IL-7, IL-8, IL-12, IL-12p40, IL-12p70, IL-15, IL-17, IL-18, IL-23, TBF-β, and TNFRI/II! Your disease will have some mix of pro-inflammatory cytokines going on and manipulating the microbiome can decrease demands on the immune system to send out these enforcers and positively affect disease state. I hope researchers include impact to cytokines in subsequent evaluation for microbiome studies. This post reports on [Kang et al 2019] which is a TWO year follow-up study of [Kang et al 2017], which was a small pilot trial that used an 8 week FMT intervention for 18 children with Autism Spectrum Disorder (ASD). They evaluated FMT impact to GI symptoms, behavior, and the gut microbiome. The conclusion of the 2019 follow-up study was that GI and behavior symptoms continued to increase or improve, and microbial diversity continued to increase and looked more similar to their donors based on 16S ribosomal RNA (rRNA) microbiome sequencing, FOLLOWING the original Microbiota Transfer Therapy (MTT) intervention. Participants still had an average of a 58% reduction in GI symptoms and a 45% decrease in ASD symptoms compared to baseline. In addition, the parents of most participants reported a slow but steady improvement in core ASD symptoms during treatment and over the next two years., and that’s why the 2 year follow-up study was done. The study suggests that the recipients didn’t retain completely the donated microbiome, but rather retained some features of it such as increased overall diversity, and increase in some important microbes such as Bifidobacteria, Prevotella, and Desulfovibrio while finding a NEW state. The authors note that these encouraging observations demonstrate that “intensive MTT intervention is a promising therapy for treating children with ASD who have GI problems.” They recommended future research include double-blind, placebo-controlled randomized trials with a larger cohort. Read on to learn the power of microbiome manipulation, no matter what method(s) you employ! \O/
Tag Archives: Clinical Trials
Weight and Avocados (Replace Refined Carbs with Half or Whole Avocado)
Summary: Few studies look at the role of nutrient combinations (particularly fat and fiber) to enhance satiety. With avocados the rage now, many wonder about the impact on their waist from eating avocados because they are high in fat. What most don’t realize though is that avocados are inherently rich in fiber and that fiber/fat combo should remind you of another functional food (i.e., nuts) which have loads of documented health benefits! Spoiler alert: If you haven’t begun yet to add avocados to your meal, read on. This newly published study found that those replacing refined carbohydrates with fat and fiber (from avocado), as part of a meal, felt significantly less hungry and more satisfied after 6 hours, compared with those who ate a low-fat, high-carbohydrate meal. Spoiler alert: They also found that this group had a healthy metabolic hormonal response, and that combo can help mitigate overweight and obesity! In other words, isocaloric dietary manipulation with a whole avocado promotes favorable metabolic responses in addition to enhancing satiety and reducing motivation to eat. This study was a randomized three-arm crossover clinical trial, [Zhu et al 2019], and it published in the journal Nutrients. The researchers looked at how meals that SUBSTITUTE a half or whole fresh avocado for refined carbohydrates affects hunger and meal satisfaction both subjectively and physiologically over 6 hours, in overweight and obese adults. Many of us are eating low-fat, high-carbohydrate meals so from a practical standpoint, the population studied represents a typical cohort of middle-aged people at risk for cardio-metabolic disease—a point when realistic dietary changes can make a significant impact on reversing the disease risk trajectory. The cohort, N=31, was relatively healthy overweight or obese volunteers having elevated fasting insulin concentrations with insulin resistance [27]. Listen up –> The important physiological implications learned from the study was that the addition of avocado limited insulin and blood glucose excursions, and this correlated with an intestinal hormone called PYY which is an important messenger associated with the physiological response. What that means is that this study provides more evidence that adding healthy fats and fibers into a regular daily diet can modulate blood sugar and insulin spikes and that can reduce the risk of diabetes and cardiovascular disease. Britt Burton-Freeman, Ph.D., the senior study author and director of the Center for Nutrition Research at Illinois Tech said, “The responses on the different satiety variables was surprising and helps us understand [or] think about how the fat and fiber may work to enhance satiety, even later, in the post-meal period.” End-game thought: E- A -T AVOCADOS in place of the refined carbs!
Healthy Pregnancy Diet. Melody Trial is now recruiting
Summary. If you are a pregnant mom (less than 27 weeks pregnant), or planning to become pregnant and wondering about a healthy pregnancy diet, please consider participating in the MELODY Trial, ClinicalTrials.gov Identifier: NCT03850600, WHICH IS NOW RECRUITING! I am super excited about this trial because it is recruiting pregnant aged women to participate in a study that will evaluate the efficacy of a diet intervention during the third trimester of pregnancy. The study’s goal is to determine if manipulation of the mothers microbiome, through diet, would benefit their baby. The diet aims to promote a healthier immune system during a critical time of immune system development. I am helping to recruit for the trial which will have 396 participants, having and not having autoimmune Crohn’s disease. Details for the trial are below. Guys, if the MELODY Trial works for IBD, to improve the microbiome and baby’s immune system, will this strategy work for other diseases?!? Please, do your part and share this info with your friends, daughters, gynecologists, GI docs, doulas… Lets load this cohort quickly and move the needle to make the future better for our next generation! We’ve messed so many things up microbiome-wise, WE OWE OUR CHILDREN THIS!
Melody TRIAL- Can Maternal Diet Reduce Disease Transmission to the Newborn?
SUMMARY: I am beyond excited to begin 2019 with the announcement of a groundbreaking microbiome study that I’ve been asked to help spread the word on! The study, called the MELODY trial, peels back the layers of microbiome influence further than any study I’ve seen to date because it moves the needle for microbiome manipulation PAST the immediate host to hopefully influence and alter the health of the newborn! HOW? The MELODY Trial will recruit childbearing aged women to investigate if changing the maternal diet can reduce transmission of disease to the newborn! The Melody Trial will focus on Inflammatory Bowel Disease (IBD) because children born to mothers with IBD have increased risk of IBD. Participant recruitment is targeted to begin mid-January, 2019. Its website is coming soon, and I’ll post that info ASAP! However, to start this discussion and catch all up to speed, this post explains another study called the MECONIUM Study (see the link here) and its EIGHT publications are below! MECONIUM stands for Exploring MEChanisms Of disease trasmission IUtero through the Microbiome. I’m starting here because the MELODY trial is based on the preliminary findings of the MECONIUM Study! The primary investigating lab for both studies is Peter Lab, Icahn School of Medicine at Mount Sinai. The MECONIUM Study was a prospective study that explored the role IBD plays in the composition of the maternal and infant microbiome. The MECONIUM Study found that the dysbiotic microbiome seen in infants born to mothers with IBD can be improved when ENVIRONMENTAL factors known to have a negative effect on the microbiome are ABSENT in early life. In particular, the sub-optimal microbiome of babies born to IBD mothers were MITIGATED in early life when the baby was born vaginally, was not exposed to antibiotics, and was exclusively or partially breastfed. Because of these findings, and since DIET is also considered an environmental factor that can change the gut microbiome, the MELODY Trial investigates if IBD mothers consuming the UMass IBD-AID diet (a diet shown to change the gut microbiome to anti-inflammatory, aid in repair of the gut, and help restore balance to the immune system to help induce remission for IBD), also alters the vaginal microbiome and reduces the risk of transmitting the dysbiotic disease-prone microbiome to the newborn. Guys, if the MELODY Trial works for IBD, will this strategy work for other diseases?!? Please, do your part and share this info with your friends, daughters, gynecologists, GI docs, doulas… Lets load this cohort quickly and move the needle to make the future better for our next generation! We’ve messed so many things up microbiome-wise, WE OWE OUR CHILDREN THIS!
SCD PALEO Cucumber Salad (Mediterranean, Whole Foods, SCD, GAPS, PALEO, AIP)
Summary: This is the second of five family fav vegetable redic delic recipes I’m posting –> SCD PALEO Cucumber Salad. The first posted at SCD PALEO Cauliflower Mock Potato Salad! These salads meet all healing diet tenets be it: Mediterranean Diet, Whole Foods, SCD, GAPS, PALEO, AIP… You can add whatever vegetables you want to help meet the target of 30 different vegetables each week to increase microbiome diversity! These salads are also great topped on leafy greens! ♥ The BIG thing to learn in this post is that cucumbers are high on the EWG Dirty Dozen pesticide residue list (they are listed fifteen) so buy them organic if possible. Regarding the green peel, I recommend you peel cucumbers unless you can confirm there is NO coating, even if the cucumber is organic. I don’t want your gut seeing coatings! To avoid coatings, try growing cucumbers in your garden ⇒ they grow insane in ours! Or source from a farmer you trust! Of course this recipe usesunadulterated EVOO ⇒ those are listed on this UC Davis PDF report. Costco Kirkland Organic or California Ranch are listed as unadulterated on this report. Unadulterated EVOO is a heart AND brain healthy monounsaturated fat. This oil is a predominant ingredient on the Mediterranean Diet and MIND diet! The MIND diet stands for Mediterranean-DASH Intervention for Neurodegenerative Delay. It combines Mediterranean, DASH, AND aging brain literature. Learn a bit more about it here! ♥ It’s the first time I’m posting about it, but contact me to learn How-Tos, Workshops, or for CME! XO
Intervention Diet Weight Loss Study
Summary: It is NOT calories in, calories out. This Intervention Diet Weight Loss Study is looking to show just that. It is being conducted by five prestigious universities: Framingham State University, Boston Children’s Hospital, Indiana University Bloomington, University of Alabama at Birmingham, and Baylor University! The study evaluates the effect of dietary carbohydrate and sugar consumption independent of energy content on body fatness and metabolism in a rigorous feeding study. The study looks at WHY diets high in total carbohydrate, with or without added sugar, acts through increased insulin secretion, all during substrate partitioning towards storage and body fat, leading to increased hunger, slower metabolism, and accumulation of body fat. This is a randomized controlled feeding study involving 128 adults with BMI between 27 to 40. The test diets include very low carbohydrate (about 70% fat), High carbohydrate low sugar (25% fat, 0% added sugar), and high carbohydrate high sugar (about 25% fat, 20% added sugars).
Study Recruiting for Antibiotics, Autism Symptoms
Summary: The 2014 1st International Symposium on the Microbiome in Health and Disease with a Special Focus on Autism brought out anecdotal parent findings that autism symptoms improved or worsened on antibiotics. Baylor College of Medicine study in conjunction with Texas Children’s Hospital, is now investigating those findings! If you have an autistic child, consider enrolling now before they are sick, so you have a test kit if prescribed an antibiotic over the next two years. You would send microbiome samples pre and post the antibiotic. Those are to be evaluated for changes to behavior and the microbiome — the bacteria, yeasts and fungi that also inhabit the gut, as well as examining metabolites (small chemical molecules) found in the GI tract. The study is free to participants and fully paid for by N of One: Autism Research Foundation which is founded by John Rodakis, the father of an autistic son who experienced symptom improvement due to an antibiotic dose Thanksgiving 2012. Participate if you can to increase understanding of Antibiotics, Autism Symptoms which at present, has a gap in the published autism research. This initial data may more effectively sub-type autism and develop and deliver more effective microbial-based interventions.
Lots of children have autism.
Data from 2014, and confirmed in 2016, show 1 in 42 boys and 1 in 189 girls have autism. This is often put as one in 68 children have autism. The prevalence chart below shows the alarming autism increase since 2000. Also startling, the number of children with autism varies widely by community, from 1 in 175 children in areas of Alabama, to 1 in 45 children in areas of New Jersey. See CDC Autism State Report, 2014 and CNN Report, Autism rates now 1 in 68 U.S. children: CDC.
Autistic children’s microbiome metabolites (the exhaust of the gut microbiota) differs compared to children without autism.
Several studies have reported significantly higher oral antibiotic use in children with autism versus typical children (6, 14–17). Antibiotics cause collateral damage to the microbiome. From the 2016 review, The effects of antibiotics on the microbiome throughout development and alternative approaches for therapeutic modulation: The use of antibiotics heavily disrupts the ecology of the human microbiome (i.e., the collection of cells, genes, and metabolites from the bacteria, eukaryotes, and viruses that inhabit the human body). A dysbiotic microbiome may not perform vital functions such as nutrient supply, vitamin production, and protection from pathogens [3]. Dysbiosis of the microbiome has been associated with a large number of health problems and causally implicated in metabolic, immunological, and developmental disorders, as well as susceptibility to development of infectious diseases [4–11].
Finally, an IBD microbiome drug goes to clinical trial
Summary: Seres Therapeutics began its Phase 1b placebo controlled clinical trial on Dec 14, 2015, for SER-287, which is the first drug aimed at the microbiome for a non-infectious, chronic condition, ulcerative colitis (UC). This is the first IBD microbiome drug that actually targets the constituents of the microbiome. This approach treats chronic disease without suppressing the body’s immune response. Instead, specific strains of bacteria are introduced that re-balance the billions of different types of bacteria that are in the digestive tract, which then increases immunity and manages the disease. Instead of being immunosuppressive, this treatment targets the root cause of UC which is gut dysbiosis, increasing immunity. SER-287 clinical trial is currently recruiting participants if you are interested; contact information is below.
Note: The immune system outsmarts anti-TNF meds a lot of times — 30 to 80% of the time for IBD. Isn’t that a crazy broad failure range? This post speaks to some of the whys of that failure. And… realize a lot more diseases use these immunosuppressive meds beyond IBD.
I wrote about the immunosuppressant and biologic microbiomes not looking ‘healthy’ in this post, and in fact had the opportunity to have that very question answered and confirmed by Johns Hopkins GI expert Dr. Gerard Mullin, MD at the Evolution of Health Functional Forum, called Microbiome Maximized Medicine, held in NY on October 5, 2015. The YouTube of that dialogue can be linked to on this post.
These disease microbiome drugs are not immunosuppressive, rather their mechanism of action is to enhance and increase immunity.
Incidentally, healing diets also introduces microorganisms and food substrate matter into the gut that cause mucosal healing with increased immunity to manage chronic disease
I wrote about the microorganisms we ingest at: AVG NUMBERS AND KINDS OF MICROORGANISMS CONSUMED IN A DAY. Interestingly, the USDA dietary pattern had the highest total microorganisms for the day, due to yogurt and cottage cheese consumption, whereas the AMERICAN and VEGAN dietary patterns had 3 orders of magnitude fewer total microorganisms primarily due to heating probiotic type food such as cheese (which kills microorganisms) or the diet lacks consumption of probiotic type foods. I am certain the FODMAP type foods omitted or ingested also impact microbiome richness since these food substrates are food for bacteria which if provided, will accordingly bloom bacteria. See here for a FODMAP post. Healing diets contain unheated live fermented foods and tolerable FODMAPS and have been shown to increase microbiome diversity and immunity in compromised guts. See this post for IBD: 50 IBD SCD REMISSION PATIENTS: RUSH PAPER.
“Bugs as drugs” idea for disease treatment
Startups are harnessing the trillions of bacteria inside us to eradicate chronic disease such as diabetes, obesity, arthritis, MS, autism, depression, and more. This “bugs as drugs” idea for disease treatment packages live strains of bacteria originating from a healthy donor’s microbiome to be used as therapy.
This all began as a fecal microbial transplant (FMT) which is currently approved for antibiotic resistant CDiff infection and has over 90 percent cure. A startup that provides FMT substrate matter originated out of a not-for-profit from MIT and is called OpenBiome. Mark Smith is OpenBiome’s founder who considers that the oral application wouldn’t just reduce the discomfort of the FMT transplant, but that “swallowing a capsule of someone else’s healthy digested material — [that’s where the live strains of bacteria are coming from] or eventually swallowing strains cultivated in a lab,—could become a maintenance therapy for sufferers of a variety of gastrointestinal disorders, and for that, “We’re in the testing and evaluation phase.” Side bar: Anecdotal evidence from my follow of numerous DIY groups does lean towards needing repeat FMT for some diseases. Diet impact post-FMT microbiome is not well understood (nor is it understood pre-FMT for the donor) which could impact acceptance of the transplanted microbiome sooner.
“FMT are not the way of the future. They are just a transitional solution… [for OpenBiome’s capsule, the first patient to test will be] a quadruple amputee with C. diff. She’s not a good candidate for a fecal transplant, but her doctor thinks this pill might be perfect.” –MIT Lab Hosts Nation’s First Stool Bank, But Will It Survive? and WHAT’S LURKING IN YOUR MICROBIOME? POSSIBLY, A CURE FOR DISEASE
Why start with IBD for “bugs as drugs”?
The short of it is, they are picking diseases with known causation being gut dysbiosis; there is a difference with correlation and causation. “If you’re going to leverage the microbiome for drug discovery, it’s not the correlations that matter. It’s the causal relationships. How are the bacteria interacting with the host in a way that’s driving our biology? Did patients with bowel or intestinal diseases—colitis, for instance—have different gut bacteria profiles because they were ill? Or were they ill because they had different gut bacteria profiles? For example, children with autism often have significant gastrointestinal problems. Yet is that a reason for their autism, or is it just a related fact?” -WHAT’S LURKING IN YOUR MICROBIOME? POSSIBLY, A CURE FOR DISEASE
The diseases in the right quadrant represent those with known causation as microbiome dysbiosis. Left quadrant diseases have been associated with gut dysbiosis. DiLaura, of Second Genome, explains, “So our efforts, right now… aims to create a drug for IBD. Difficult as that sounds, it is a modest goal compared to the company’s second order of business: create a drug for metabolic diseases like type 2 diabetes. The first drug, if effective, could affect hundreds of thousands of people; the second, millions”. -WHAT’S LURKING IN YOUR MICROBIOME? POSSIBLY, A CURE FOR DISEASE
Background on Seres medicines
All of Seres’ medicines are made up of biologically-sourced bacterial spores (which are very different from fungal spores) which can be collected in a capsule for easy administration.
The first drug candidate from Seres to reach clinical trials is for treatment of Clostridium difficile infection (CDI) in adults; this drug. SER-109, is now in Phase 2 trials and is a mixture of bacterial spores from 50 bacterial species taken from healthy donors. Currently, FMT is used to treat recurrent antibiotic resistant CDI with over 90 percent cure.
SER-287 is the second Seres drug joining alternative capsule treatment for FMT but this time for UC. SER-287 is a microbial cocktail capsule containing “a complex and diverse bacterial spore ecology.
I am concluding the specific microbial composition of SER-287 is sourced from healthy donors as is SER-109; the trial is looking at engraftment of SER-287 bacteria into the intestinal microbial community. Ordinarily, commercial probiotic bacteria such as in yogurt, does not engraft into the microbiome. These bacteria are transient and repeated consumption is required to maintain and sustain benefit. Benefit often ceases about 3 days post consumption.
If you want further detail on Seres, see Seres therapeutics website.
Clinical Trial details for SER-287, the first IBD microbiome drug that targets the microbiome
The link to the study is: A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Ulcerative Colitis. About 55 patients are expected to enroll; the trial is currently recruiting participants. The drug used, SER-287, treats UC without suppressing the body’s immune response. Instead, SER-287 delivers specific strains of bacteria to re-balance the billions of different types of bacteria that are in the digestive tract, which then manages the disease. This treatment is not immunosuppressive; instead it targets the root cause of UC which is gut dysbiosis.
The current standard of care for UC treatment uses drugs that suppress the immune system to reduce inflammation in the colon and rectum which makes patients susceptible not only to infectious diseases, but to cancers that would otherwise be killed off by the immune system.
Primary Outcome Measures of the Clinical Trial:
- Safety and tolerability of SER-287 vs. placebo in adult subjects by analysis of AE’s, lab values, vital sign, physical exam findings, medical history, and ECG.
- Examination of baseline composition of the intestinal microbiome to the composition. Changes in the composition of the microbiome will be characterized by rDNA 16S V4 genomic data sets. Changes will be assessed by total number of unique bacteria and microbial composition.
- Engraftment of SER-287 bacteria into the intestinal microbial community. Microbiome will be characterized by rDNA 16S v4 Genomic Data Sets. Engraftment will be assessed as the outgrowth of bacteria that compromise the SER-287 spore ecology in the subjects GI tract post treatment.
The time frame for the study
December 2015 to June 2017.
Contact for the study
Michele Trucksis, PhD, MD at clinicalstudies@serestherapeutics.com
Study Locations are:
- United States, Florida. Advanced Gastroenterology Ctr, Port Orange, Florida, United States, 32127. Contact: AMMAR HEMAIDEN, MD 386-763-4920
- United States, Maryland. Capital Digestive Care, LLC – Metropolitan Gastroenterology Group (MGG), Chevy Chase, Maryland, United States, 20815. Contact: ROBERT HARDI, MD 240-737-0085.
- United States, Massachusetts. Community Clinical Research Network, Marlborough, Massachusetts, United States, 01752. Contact: JOHN CURRAN, MD 508-320-9248
You can read more about Seres and SER-287 here:
CEO: Seres Therapeutics ‘walks into flying’ with new trial in ulcerative colitis:
As to why they are targeting UC and not a larger population affected condition such as Type 2 Diabetes or Metabolic Syndrome: Pomerantz, CEO of Seres explained, “As someone who’s worked on eight infectious disease drugs, I know that you want to walk into flying. You don’t want to fly into flying.” Seres intends to target metabolic diseases in addition to inflammatory and infectious ones, but other recent microbiome startups are looking even further, at fields like autism or others. Pomerantz maintains that while such diseases may be in the realm of those which can be treated by rebalancing the microbiome, “we don’t think that was smart” to start with them.
SCD thoughts given DrOz 3 Day Cleanse, Microbiome
SUMMARY: Finally! A peek into our trillions of innards on a 3 day fruit and vegetable blitz! Spoiler alert: There is NOT much impact 10 days after stopping that 3 day cleanse, microbiome resulting from healing diet tenets persist!
And that, I think, is the lesson to be learned for the healing diets such as SCD, GAPS, PALEO, AIP, WAHLs, to name a few. Realize, the tenets of these healing diets are for everyone if you want to prevent chronic disease, not just those with chronic disease. These protocols increase vegetables and fruits beyond what the normal Standard American Diet (SAD) yokel is consuming and adds in healthy fats so fat soluble vitamins are actually absorbed. This is done concomitant with ditching processed foods, including processed sugars, and other inflammatory foods. How powerful are these tenets? They are healing and inducing remission in messed up impoverished gut microbiomes, and some of those folks are only 80% compliant with the diet! Nuff said. Shouldn’t you know what these tenets are?
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.
Please pass this post on so that others can participate too!
Automatic communication
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 :
- Differentiate between IBS versus IBD diagnostic workup in patients presenting with diarrhea, and
- 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)
My hope is that this motivation allows these patients to address anti-inflammatory dietary management to preclude relapse. See the posts:
- PRESERVE & RESTORE LOSS OF MICROBIOME DIVERSITY IS AGGRESSIVE PREVENTATIVE MEDICINE
- IBD CAM [LDN, PROBIOTICS, SCD…] & INTEGRATIVE MEDICINE BENEFITS GUT HEALTH, and
- NICE, SCD INCREASED F. PRAUSNITZII… HUGH?!?
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
https://www.youtube.com/watch?v=38p0zuQUCWY
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.
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!
Three easy steps to performing the home test
Extract sample and run test
Fast and simple sample collection and test cassette loading with the CALEX® Valve extraction device.
Take picture
CalApp® turns your smartphone into an easy to use test cassette reader.
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®
- A study of 146 patients with ulcerative colitis showed calprotectin levels that were measured using a technology identical to that in the IBDoc, and
- 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.
IBdoc 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.”