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If all you’ve ever considered poop to be is a waste product, think again. Poop is beneficial. Poop saves life. Poop is money, big money!
The population of microorganisms within the human gut is called microbiota. This microbiota is complex and functions like an organ. Dysbiosis is an abnormal modification of this population.
Dysbiosis has been linked to several disease conditions like Clostridium difficile infection (C.diff), inflammatory bowel disease (ulcerative colitis or Crohn’s disease), irritable bowel disease, metabolic syndrome, obesity, behavioral disorders, to mention a few.
Can we correct Dysbiosis?
Fecal microbiota transplantation (FMT) or stool transplant is a procedure in which stool or fecal material is collected from a healthy donor, processed, and then transplanted to a recipient. FMT dates back to 4th century China but the first case series of its efficacy were published by an American surgeon in 1958. Since then several case series and a randomized controlled trial in 2013 have established its efficacy (average cure rate of 90%) for severe or recurrent C.diff.
According to the Centers for Disease Control and Prevention (CDC), C.diff caused half a million infections in the U.S in 2011 and 29,000 died within 30 days of initial diagnosis. There is no therapy as effective as FMT for severe or recurrent C.diff.
According to the CDC, an estimated 1-1.3 million people suffer from inflammatory bowel disease (IBD) in the U.S. In the July 2015 edition of Gastroenterology, FMT was shown to induce remission in patients with active ulcerative colitis in a randomized controlled trial. More studies are needed to confirm this important finding. If confirmed, this could be revolutionary.
Several questions persist with FMT;
»What are the long term consequences of FMT?
»How can we better screen donors? What is the best mode of delivery?
»What is the right dose and frequency?
»How do we remove regulatory barriers, yet protect patients?
“Anytime there is a problem, there is a start-up.“
So what are the opportunities for start ups and commercialization of poop?
1. A stool bank. OpenBiome, a non-profit stool bank founded a few years ago by graduate students at M.I.T had $578,131 in gross profit according to its 2014 financial statement; Rebiotix is a privately held biotechnology company founded in 2011 with plans to sell microbiota stool suspension.
2. Donor assessment. While some organizations like AdvancingBio handles every aspect of FMT including donor screening, collection, testing, processing, and shipment, a company may focus on just donor recruitment and assessment.
3. Stool processing equipments. Before use, stool needs to be diluted (usually with tap water, milk or normal saline) and homogenized (often with a blender or manually). Machines that can process stool more efficiently are needed.
4. Cheaper microbiota assessment. It is currently time consuming and expensive to perform a microbiota profile of stools. Cheaper, portable and durable kits are needed.
5. Encapsulated formulations of fecal material. This is already happening and may remove the Yuck! Factor.
6. Compliance solutions. The regulatory headache associated with FMT is daunting. Companies that can streamline the regulatory huddles can make a difference.
7. Post-marketing surveillance registries. Like all transplant recipients, ideally all FMT recipients should be monitored regularly to ensure long term safety.
The application of FMT is still in its infancy but the future looks promising. Start-ups can take us there.