Fecal Microbiome Transplantation

Our Bac-in-a-Boc capsules allow the delivery of members of the microbiome by the oral route, simplify treatments and making them more acceptable and routine. Our Bac-in-a-Box technology protects from acid degradation and loss of bacteria in the stomach, allowing stoichiometric delivery to the lower intestine.

Recent studies have demonstrated that the microbiome plays a critical role in facilitating host metabolism and makes major contributions to the regulation and maintenance of host physiology, as well as to the development and homeostasis of immunity and the nervous system. Imbalances (dysbiosis) in the gut microbiome are associated with pathogenesis and/or progression toward a broad spectrum of diseases including:
Clostridium difficile infection- infectious disease
inflammatory bowel disease- intestinal immune-mediated disease
celiac disease- multisystemic autoimmune disorder
obesity- metabolic disease
colorectal cancer- cancer
autism spectrum disorder- neuropsychiatric disorder
depression- neuropsychiatric disorder
alcoholic liver disease- acquired disease

Redressing the balance of the microbiome can treat and even cure such diseases. The classic way to do this is via Fecal Microbiota Transplantation (FMT) in which the processed stool from “super donors” that is enriched in certain microbial strains is given orally or via endoscopic delivery, naso-intestinal tube delivery or retention enemas, all of which are invasive and mostly require hospitalisation.

Advantages of encapsulating cells:

The ability to provide individual or mixtures of members of the microbiome by the oral route, e.g. in capsules, would very much simplify such treatments and make it more acceptable as well as more routine. However, the acidic environment of the stomach makes the oral delivery route challenging. Indeed stomach acid evolved as a means to “sterilise” food before it enters the small intestine and transits through to the large intestine.

Our encapsulation technology, Bac-in-a-Box®, is based on a modified natural polymer, cellulose sulphate, that is particularly good at protecting microbiome bacteria and yeast from the cell killing effects of low pH, as found in the stomach. To survive passage through the stomach, Bac-in-a-Box are able to withstand up to 4 hours at pH 2, since ingested material can reside for as long as 4 hours in this highly acidic environment. Encapsulation using Bac-in-a-Box® results in up to 9 logs protection over a 4 hour period as compared to free (nonencapsulated) bacteria and yeast. Furthermore, the encapsulated bacteria are then released in the lower intestine which, subsequently, they have been shown to colonise.

Use of Bac-in-a-Box is ideal to produce “off the shelf” oral products based on either super donor material or well defined mixtures of therapeutic bacteria which can even be stored at room temperature, rather than needing refrigeration, to simplify storage and logistics, due to Bac-in-a-Box’s unique ambient storage properties.