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Microbiome Drug Fails

MicrobiomeBy Teresa Conrick

Since my recent report on Autism and the Microbiome: Will Fecal Transplants Be the Next “AWAKENINGS?" Part 2, there has been a recent update in the news:

Gut check: Seres Therapeutics shares plunge after microbiome drug fails in trial:

Shares of Seres Therapeutics plummeted more than 69 percent Friday after its microbiome treatment for preventing a bacterial infection failed in a mid-stage study and raised doubts about this growing area of research. 

The product, known as SER-109, is a mix of bacterial spores designed to treat patients from recurring infection of the potentially deadly bacterium Clostridium difficile, or C. diff.

In a phase 2 study, SER-109 did not reduce the risks associated with the infection, compared to the placebo, at up to eight weeks of treatment.

....Seres Chairman and CEO Roger Pomerantz said, in a press release, that the clinical results were "unexpected" in view of positive data in prior investigations and supporting clinical data.... investors saw the results as potentially warning about the entire area of microbiome therapeutics, which has been looked on with much promise. The burgeoning field looks to treat illnesses by adding "good" bacteria to your digestive tract.

Seres is one of several companies racing to do that. Others include Vedanta Biosciences, Enterome, Second Genome and uBiome.

So for many, like myself,  looking at the Microbiome as key in GI diseases and also gut/brain disorders like Autism, do not give up hope.  Although pharmaceutical companies would like to learn the recipe for transforming a sick Microbiome to a healthy one via Efforts are under way to turn bacteria into regulated pharmaceutical products to treat illnesses of the gut, where the microbes reside, it could be more research is needed.  So far, the non-pill type is showing much promise but research may figure out more on how to help our kids with very sick Microbiomes.

Teresa Conrick is Contributing Editor for Age of Autism.


Hans Litten

Watched a documentary about Dr Theodor Morell , physician to Mr Adolf Hitler .
Adolf was won over by Dr Morell (who I understand may have been jewish) after he performed what was a type of fecal transplant that cured the fuhrer's ailing intestines .

Obviously it would have been better if Dr Morell hadn't bothered but interesting nonetheless.


This link to the us patent office on potential fecal transplant specifics from one single patent filing will give you a really good idea of how complex the process is, or how complex it is becoming in order to be patentable, obviously with a multitude of long term treatments in mind, including adding vitamins and minerals into the mix. However, it also shows in the process the use of many chemicals of concern for purification and enhancement, such as this section "In another embodiment, the composition comprises a lubricant as an excipient. Non-limiting examples of suitable lubricants include magnesium stearate, calcium stearate, zinc stearate, hydrogenated vegetable oils, sterotex, polyoxyethylene monostearate, talc, polyethyleneglycol, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate, and light mineral oil."

or this

"In some embodiments, the composition comprises at least one carbohydrate." yikes! what kind? what if one has celiac?

or this

"In yet other embodiments, the composition comprises a coloring agent. Non-limiting examples of suitable color agents include food, drug and cosmetic colors (FD&C), drug and cosmetic colors (D&C), and external drug and cosmetic colors (Ext. D&C). The coloring agents can be used as dyes or their corresponding lakes." yikes! what if one was the type of person who needs a feingold diet?

There were flavoring potentials listed, too? Will they be making gummies and call them "Poo-Chews?!"



Hmmmm, buy low, folks!

I've been trying to read a bit more about this company and their product. I can't quite tell if this a 100% natural product, or if it is a selected genetically modified confab withmixed human bacteria mixed in, but I can see that their defined clinical protocol changed in one of their trials, maybe the one the article talks about. That warrants a second look. It's not talking percentages of patients helped, but in the one with the changed protocol, the protocol change was supposedly to continue to treat, or retreat or something, the patients that DIDN'T get helped by the original pre-protocol-change treatment. Although its a big assumption, I assume that means that people WERE helped at some point, but there are still non responders, AND i think the extension criteria for participation look a bit looser than the original group.

I also know that the late Dr. Nicolas Gonzalas talked about how his clinical trial may have been scuttled by people running the trial that were working with the participants by changing his approach resulting in negative outcomes. And we know from the MMR whistleblower trial in pennsylvania what can be done behind the scenes to portray positive outcomes. We've seen brain samples in high tech double protected refrigeration units thaw under mysterious circumstances.

So we know things can be made to look bad or good, depending on what someone wants.

Maurine Meleck

Thanks Teresa for this report. Sorry to hear it didn't go well. I'm keeping my chin up though..........
Glad your are now well Jenny Allan.


This gut stuff is complicated.

It is not so easy to reverse after you get a gut all messed up.

Change of diet might be just as important too.

Gary Ogden

I saw this story last week, and was not particularly surprised. Biology is complex, and pharmaceuticals generally have modest effects. I may be wrong about this, but I don't think human poo is patentable. Yet fecal transplants have had remarkable success with C. diff. Microbiome research remains very promising for healing, but, like much in medicine, the difficulty ahead is the pharmaceutical model of health, and the capture by industry of the direction of academic research and government funding streams.

Jenny Allan

EEK!!! I'm a survivor of C.diff and spent years campaigning for safer hospitals and public awareness in the UK . I won't bore you with all the official and unofficial 'knockbacks' I got. It eventually dawned on me that 'vested interests' had got hold of this crisis in our hospitals and were determined to make money out of it. No-one was interested in cheap, simple preventative measures for Clostridium difficile, but I can tell you probiotics DO prevent this potential killer bug, and can ameliorate the infection, even when it has taken hold, and I should know. I was infected in hospital 10 years ago and believe probiotics saved my life . You do not need to be a scientist to understand an illness caused by depletion of friendly gut flora by antibiotics, can be countered by probiotics, easily available in live yogurt drinks and more expensively within special capsules, designed to resist digestive acids and survive to populate the colon.

Much has been said and written about hygiene practices in hospitals, but hand washing and alcohol gels make little impression on C. diff bacterium spores, which like Anthrax spores, can persist for years in cracks and creases, and can survive heat and strong disinfectants. A myriad of commercial 'deep cleaning' systems and machines, all costing a fortune, sprang up, all promising to eradicate the bugs from infected premises. In England, a vaccine was developed and got as far as clinical trials in the UK. I assume this was an expensive failure, since I have heard nothing since.

I have no detailed knowledge of the product listed above, SER-109, a mix of bacterial spores, but it is just one of dozens of similar products available. I take a daily probiotic capsule, available in my local supermarket and pharmacy, and have had no C.diff recurrence. My husband has a daily probiotic yogurt. When he was in hospital I brought them in for him each day, (with the surgeon's permission). I keep a supply of special capsules with a mix of friendly bacteria and a special yeast. These are kept for when family members need antibiotics, or are going into hospital. One capsule a day for a week before and a week after hospital keeps C. Diff at bay. I should mention here the main treatments for C.diff infections are two powerful antibiotics, Metronidazole and Vancomycin; both will also kill off oral intakes of bacterial probiotics, hence the yeast. Timing the probiotics for midway between antibiotics is essential.

Faecal Transplants or Bacteriotherapy have been proven effective for recurrent C diff infections, hard to treat using conventional means. These MUST be carried out by registered practitioners.


It seems that the problem here - which we've been fooling ourselves for over a Century with - is that we see a single, synthetic DRUG, made and sold for profit, as the "magic pill" which will CURE us of our ills.... This is mechanistic, materialistic, and reductionist. It's not only the "medical model" we've been slaving under. It's also the monetary & financial model we've been fooling ourselves with.... Sure, there may be "promising" lines of "research" here, but it's geared towards making a $$$ profit, not HEALING....
Is anybody asking what foods are best to feed the healthy gut biome?....

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