Category Archives: Blog: Clinical Trials-Diet/Environment/Disease

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.

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Breast microbiome and Cancer Risk Assessment tool

SUMMARY:  Recent studies challenge dogma and find that healthy breast tissue is NOT sterilafter-all. The breast seems to have its own microbiome of bacteria and such seems protective; dysbiosis (REDUCED richness and/or certain species) was associated with breast cancer.   Furthermore, healthy breast tissue had bacteria  Sphingomonas yanoikuyae (Proteobacteria), which is better known to degrade pollutants in the environment. In the cancer samples, there was little to none of S. yanoikuyae; this bacteria is able to use estradiols including 17-β estradiol, which are believed to be associated with breast cancer. The authors could not determine causality due to lack of S. yanoikuyae. Learn in this post microbiome implications for breast cancer, free online breast cancer risk assessment tools, ongoing studies personalizing cancer risk for mammogram frequency to reduce false positives, and look over a decent listing for cutting your risk for breast cancer in the first place from Prevention. Included specifically on that list is carotenoid loads which I preach about, including the need to consume carotenoids with the correct healthy fat so as to absorb them. LOWFAT DOES NOT ABSORB THOSE CAROTENOIDS.

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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.

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50 IBD SCD remission patients: RUSH paper

SUMMARY:  In August, 2015, RUSH University published  their study of 50 IBD Specific Carbohydrate Diet (SCD) remission patients: The Specific Carbohydrate Diet for Inflammatory Bowel Disease: A Case Series. This is the largest report on a series of patients with IBD following the SCD to date and describes their clinical characteristics.  50 patients in remission eating SCD case series are reported which comprise: 36 subjects had Crohn’s Disease, 9 subjects had Ulcerative Colitis, and 5 subjects had in-determinant IBD.  

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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. 

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A professional autism dietary intervention program.

Summary:  It is time to share what a successful professional autism dietary intervention program can look like for autism management.

“Special Diets and Nutrition For Autism: Why They’re Cost Effective,” is such an interesting read from Judy Converse MPH RD LD, a registered dietitian since 1989, who then self taught herself, beginning in 1996, diet impact for her son’s growth, feeding, and developmental challenges at birth.   She then expanded training to learn biomedical intervention for autism, becoming a DAN practitioner, and ultimately provided instruction in nutrition for Autism Research Institute, US Autism and Aspergers Assocation, National Autism Association, and many others. She has lectured for many local and national audiences about the profound impact nutrition and a healthy gut have on the developing brain as well as authoring three books and created the first web-interface accredited learning module for health care providers on nutrition and autism in 2007.

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Alzheimer’s Diet, Microbiome, & Bio-marker Predictors

SUMMARY:  Learn the latest on Alzheimer’s Diet, Microbiome, & Bio-marker Predictors.  Such is welcome news as the latest Alzheimer’s Facts & Figures show that over 5 million Americans are living with Alzheimer’s, including an estimated 200,000 under the age of 65.  

By 2050, the number of people age 65 and older with Alzheimer’s disease may nearly triple, from 5 million to as many as 16 million.  Truly, Alzheimer’s is one of the diseases most feared in my talks; it is the sixth-leading cause of death in the United States.   The estimate is that by age 64, one in 8 will have Alzheimer’s.  That rate doubles every 5 years.  So by age 70, one in 4 will have Alzheimer’s.  And by age 75, one in 2 will have Alzheimer’s.  These stats are from a 2013  interview of Dr. Thomas Wisniewski, @ time 25:30: “Brains – The Latest Research 07/01/2013 – 08:04” (NYU Langone Medical Center Audiocast, SirusXM Dr. Radio programming), who’s lab, Dr. Thomas Wisniewski’s Lab, is one of the leading Alzheimer research labs.

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Autism Microbiome Study: 2 Studies Seek Participants

The 1st major funded Autism Microbiome Study:

“Autism Speaks Invests $2.3 Million in Research on Autism Gut-Brain Connection, which makes these studies the first major funded GI initiative that investigates microbiome, biological stress and  bowel  disorder treatment in children with autism.  

Clinical trials will span 3 years and are now filling if you are interested.  Please share this information on Facebook, Twitter, Pinterest… so that others can participate.  While this research might be a decade or so behind what parents know, it’s two decades ahead of our GP and many autism treatment facilities, so it’s needed, it’s important, and I’m very grateful to hear about it.

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Microbirth: Health Ramifications associated with C-Section birth

SUMMARY:  Learn the long term health ramifications associated with  C-Section birth.  “Microbirth” information every parent needs to view.

Microbirth is a new 60 minute documentary investigating the latest scientific research about the microscopic events happening during childbirth.  As this Press Release explains, latest research is starting to indicate modern birth practices could be interfering with critical biological processes.   From the changes that occur in the human pregnant vaginal microbiome to that microbiome which actually inoculates the baby, be it via C-section or vagina birth, these  events are now showing to have associated consequences for the health of the child and  such could have life-long consequences making our children more susceptible to disease later in life:

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Clinical Trials Lack Diversity & Microbiome = Cancer Disparity Outcomes

Under representation of minority populations in clinical trials is a real problem, and it results in significant cancer outcome disparities for under represented groups (discussed at the bottom of this post).  What this means is that the findings of clinical trials are limited and can not necessarily be generalized among those minorities under represented or omitted in the study population.  Such subgroups are missing information on how they would respond to the trial’s treatment.  “Potential racial, ethnic and other differences in response to drugs are important to FDA’s efforts to help ensure that the safety and effectiveness of drugs are studied in all people who will use the products once they are approved.” Christine Merenda, M.P.H., R.N. , Office of Minority Health (OMH) project manager.

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