■   Fecal Microbiota Transplantation: A Review of Emerging Indications Beyond Relapsing Clostridium difficile Toxin Colitis

Gut microbiota were once considered pathogenic, but the concept of gut microbiota and their influence in human health is undergoing a major paradigm shift, as there is mounting evidence of their impact in the homeostasis of intestinal development, metabolic activities, and the immune system. The disruption of microbiota has been associated with many gastrointestinal and nongastrointestinal diseases, and the reconstitution of balanced microbiota has been postulated as a potential therapeutic strategy. Fecal microbiota transplantation (FMT), a unique method to reestablish a sustained balance in the disrupted microbiota of diseased intestine, has demonstrated great success in the treatment of recurrent Clostridium difficile infection and has gained increasing acceptance in clinical use. The possibility of dysfunctional microbiota playing a causative role in other gastrointestinal and nongastrointestinal diseases, therefore, has also been raised, and there are an increasing number of studies supporting this hypothesis. FMT is emerging as a feasible therapeutic option for several diseases; however, its efficacy remains in question, given the lack of clinical trial data. Altering microbiota with FMT holds great promise, but much research is needed to further define FMT’s therapeutic role and optimize the microbiota delivery system.

....There are also emerging data on the potential clinical applicability of FMT beyond CDI in both gastrointestinal and nongastrointestinal conditions, including inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), diabetes mellitus, obesity, multiple sclerosis (MS), Parkinsonism, autism, and depression...

Because the thought of "feces" can present with some negative images as well as strict FDA regulations currently, the above"optimize the microbiota delivery system" seems to be gaining speed.

■  Science, 10 Jun 2016 http://science.sciencemag.org/content/352/6291/1261-- Five stool banks have opened their doors in Europe and the United States since 2012, the latest one earlier this year in Leiden, the Netherlands. These banks take fresh stool from donors, process it, and store it for later use in fecal microbiota transplants, a procedure in which doctors seek to restore the normal microbial balance in a patient's gut with a dose of stool from a healthy volunteer. More such banks are in the planning, yet their long-term future is unclear. Regulators have yet to decide on how to regulate the banks' products, and several companies are busy developing gut microbiome replacements that could, in the long run, make the stool banks obsolete.

Because of the potential for huge treatment possibilities, laws and policies are being developed:

■   Fecal transplant policy and legislation http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4284361/

The Food and Drug Administration has found it difficult to standardize and regulate the administration of inherently variable, metabolically active, and ubiquitously available fecal material. The current cumbersome policy, which classifies human feces as a drug, has prevented physicians from providing FMT and deserving patients from accessing FMT in a timely fashion, and subsequent modifications seem only to be temporary. The argument for reclassifying fecal material as human tissue is well supported. Essentially, this would allow for a regulatory framework that is sufficiently flexible to expand access to care and facilitate research, but also appropriately restrictive and centralized to ensure patient safety. Such an approach can facilitate the advancement of FMT to a more refined, controlled, and aesthetic process, perhaps in the form of a customized and well-characterized stool substitute therapy....

And of course a huge interest by pharma companies:

 ..."it’s one of the most interesting developments we’ve seen in science over the last several years,"...

Efforts are under way to turn bacteria into regulated pharmaceutical products to treat illnesses of the gut, where the microbes reside.  http://www.bloomberg.com/news/articles/2016-03-14/how-gut-bacteria-are-shaking-up-cancer-research

■  October 28, 2015: Fecal transplant pills: Large-scale production begins following successful dosing study http://www.openbiome.org/press-releases/2015/10/28/fecal-transplant-pills-large-scale-production-begins-following-successful-dosing-study

MEDFORD, Mass — A new pill created by a team of MIT-trained researchers provides fecal transplant therapy without requiring the traditional, more invasive stool delivery methods.

The FMT Capsule G3 pills will serve as a treatment option for recurrent Clostridium difficileinfections (rCDI) that don’t respond to standard antibiotic treatment. The pill will also serve as a new tool for researching future applications of microbiome-based therapies....The pill was created by OpenBiome, a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation therapies and catalyzing research into the human microbiome....Similar to other microbiota preparations already provided by OpenBiome, FMT Capsule G3 may be used to treat patients with rCDI under the FDA's enforcement discretion guidelines, or to treat other conditions under an Investigational New Drug application. Encapsulated FMT is a particularly useful tool for clinical research because it allows investigators to evaluate maintenance FMT therapy without requiring participants to undergo repeated invasive procedures.

■  An investigational therapy developed from healthy donor stool specimens treated with ethanol to eliminate pathogens—the resulting spores of which are fractionated and encapsulated for oral delivery as SER-109—appears to effectively treat recurrent Clostridium difficile infection (CDI) http://www.hcplive.com/medical-news/a-novel-fecal-based-treatment-for-clostridium-difficile-infection. Published ahead of print on February 8, 2016 in The Journal of Infectious Diseases http://jid.oxfordjournals.org/content/early/2016/02/04/infdis.jiv766, the phase 1b/2 trial found that treatment with the preparation not only successfully prevented recurrence of CDI in patients with a history of multiple recurrent disease, but also restored participants’ gut microbiome to a state similar to that of people without CDI.

Although fecal microbiota transplants (FMT) have been used successfully to reduce recurrence rates in patients with multiple CDI recurrences who have not responded to standard antibiotic treatment by improving the health of their microbiomes, FMT is not FDA-approved and requires informed consent from patients. On the other hand, the novel SER-109 is being developed under strict manufacturing and regulatory standards set by the FDA.

“This oral microbial preparation that contains a small fraction of the total microbiome works as well as, if not better than, FMT,” said senior author Elizabeth Hohmann, MD, chair and physician director of the Partners Human Research Committees in the Infectious Diseases Division at Massachusetts General Hospital. “These few key species seem to work in restoring a healthy microbiome, and other, beneficial species not in the capsules return, while harmful bacteria are removed. The product is also designed to be safer than FMT, by eliminating the potential for transmission of pathogens that might be present in donor fecal material."

The current study comes on the heels of two Massachusetts general Hospital studies that showed in 2014 that the use of frozen fecal material from healthy, prescreened donors could be as effective as fresh material and that acid-resistant oral capsules to deliver FMT were nearly as effective as delivery via colonoscopy or nasogastric tube.

■   Fecal Transplants Show Promise in Kids With Recurrent C. Diff  http://www.medpagetoday.com/meetingcoverage/pas/57679

15 children underwent the procedure -- seven male and eight female, with a mean age of 7.9 years, with at least three episodes of C. difficile within a 3-month period. The patients ranged from 21 months to 18 years, and had an average of 5.7 diarrheal stools per day, as well as an average of 3.3 courses of antibiotics within a 12-month period. Seven also had ulcerative colitis, while two apiece had Crohn's disease and GERD.....Following a stool transplant from a pre-screened stool bank, patients were followed up via phone at 24 hours and 1 week after the procedure and were instructed to see their GI doctor at 1 and 3 months afterwards. Three patients were hospitalized a month following the procedure for diarrhea, dehydration and rCDI. However, only one patient was actually found to have clinical symptoms of C. difficile plus a positive stool test.....characterized the procedure as exciting and said the evaluation of the microbiome will be very important for the future of this research.   "I think in the future we probably will not be using stool – we'll be using some product derived from stool – because we don't really know what the protecting organism is," he said.

So we can see that the rules in the use of fecal matter are evolving and It seems that AUTISM is on everyone's radar. 

■     A successful, streamlined regulatory policy can advance the field of FMT far beyond its current applications as gut microflora has been determined to be involved with a variety of physiological processes, including energy metabolism, immune function, carcinogenesis, and neurologic development. These findings suggest that manipulating gut microflora may aid in the treatment of numerous conditions other than recurrent CDI, such as metabolic syndrome and obesity, anorexia nervosa, autoimmune diseases, and food allergies. The potential applications are numerous, extending to non-gastrointestinal conditions as well[27,28,33].

Substantial connections have also been identified between GI health, gut microbiota, and certain neurodegenerative and neurodevelopmental disorders and those involving mood and thought[34].The discussion surrounding autism is particularly interesting. A variety of observations linking autism to the gut microflora, such as disease onset often correlating with antimicrobial administration; increased levels of particular Clostridium species found in stool samples of autistic individuals; and the alleviation of autistic symptoms following oral vancomycin, have all supported the expansion of the traditional model of the brain-gut axis to a brain-gut-microbiota axis. Such data further allude to the vast therapeutic potential of FMT[34-36]

As FMT's continues to develop, I will keep reporting on them. For all of us who love not only our kids but our pets as well, you can see some interesting similarities in this positive article, Fecal transplants in puppies cure 93% of recurring diarrhea cases  http://arstechnica.com/science/2016/03/fecal-transplants-in-puppies-cure-93-of-recurring-diarrhea-cases/. I am optimistic that FMT's can be an important medical procedure for AUTISM.  Here's a perfect example:

I'm treating my son's autism... with someone else's faeces: Mother says three year old 'came back to her' after 'miracle' treatment - and she's endorsed by celebrity chef 'paleo' Pete Evans  http://www.dailymail.co.uk/news/article-3157875/The-result-miracle-Australian-mum-claims-faeces-treatment-helped-son-s-autism-post-shared-celebrity-chef-Pete-Evans.html

An Australian mum claims she is tackling her son's autism with a controversial treatment that involves the patient receiving a mixture of saline and another person's waste.

The mum - who identifies herself as a teacher from South Australia named Kirsty - said her son was given 'the gravest prognosis' when diagnosed with autism but 'has come back' since undergoing radical treatment.

Known as faecal microbiota transplantation, the method has been criticised by medical experts who say its alleged healing powers have not been proven, but appears to have support from celebrity chef Pete Evans after he shared Kirsty's story on his Facebook page....Supporters also say the treatment can be used to treat digestive or auto-immune diseases such as irritable bowel syndrome, Crohn’s disease and ulcerative colitis.

Kirsty began her post with writing about taking her son overseas for the treatment.' Our journey has even taken us to Canada where my son had a faecal microbial transplant,' Kirsty's post on the public page read.  'We joined a research team and he is one of very few kids to have this procedure done.  'The result was a miracle. With new bacteria in his gut he awoke the day after the transplant and spoke for the first time.  'The mum said the treatment removed 'pathogens' that were 'riddling her son's body'.
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Stay tuned.

Teresa Conrick is Contributing Editor for Age of Autism.