Clostridium difficile (C. diff) is a bacterium that’s not new to us as it has been present forever in our environment. Many of us are even happy bearers of this pathogen without facing any troubles. Its not that every individual with C. diff is a patient as it is not the bacteria that’s harmful but the release of toxins by it under certain circumstances that makes someone sick. One of the common circumstances under which toxins are released include consumption of antibiotics which exists as the major risk factor for Clostridium difficile infection (CDI) due to C. diff. It was not until 1978 that CID was tagged as a major cause of diarrhea and colitis after which there was a steady increase in the rate of incidence, morbidity and mortality. Though common in the elderly population CDI spares none and mostly affects those taking antibiotics for various other medical conditions. This is one of the reasons why physician don’t encourage the use of antibiotics for all your health-related problems unless and until their use becomes indispensable. Surprisingly, for a disease whose main risk factor is antibiotics the first-line treatment for it is also antibiotics. Though CDI might be treated with a course of antibiotics there are greater chances of recurrence of the disease in more than 20% of the patients treated within 30 days of antibiotic treatment which remains a greater challenge while treating CDI. Worse, the recurrence risk doubles when CDI occurrence rates exceed 2-3 times and exceed 90% chances when the individual is above 65 years of age, suffers from severe disease and continues using antibiotics even after treating CDI. Also, inflammatory bowel disease (IBD) one of the greater risk factors for CDI infection increases recurrence rates and also the severity of colitis.
Our gut microbiota plays an important role in tuning our health. It contains millions of pathogens-bacteria and viruses-that help in the functioning of our body and protecting us against diseases including CDI. So, while a normal gut microbiota protects against CDI use of antibiotics (such as vancomycin and metronidazole) to treat CDI becomes the root cause for the recurrence of the infection in due course. Antibiotics, a number of them, have been used to not only suppress C. diff but also to preserve the residual colon microbiota. But, as antibiotics are also responsible for a major portion of recurrence of the infection physicians are now challenged with a mission to find a definite solution.
Fecal microbiota transplantation (FMT) is not something new but the only thing is that its gained popularity in the last couple of years. FMT is a method wherein stool from a healthy donor is placed into the gut of a patient as a treatment method for certain diseases. It helps to build back lost colon microbiota stores but has been considered as the last resort for treating patients with CDI owing to a number of reasons- absence of enough donors when required, difficulty in preparing and administering materials, how good the procedure would be to the patient’s eyes, how willing the staff would be to perform the procedure and issues with sanitation. Also, pharma industries haven’t shown much interest in taking FMT to the next level as donor material is widely available, its composition is highly complex and people willing to involve themselves in research are few. Rather, advancements have been made by individuals who care about their patient’s well-being.
The invention patented here is an extract or a preparation of human feces. Until this invention, the donor was mostly a close family member as this individual material was assumed to be better tolerated by the recipient’s immune system owing to prior exposure. But there are a number of disadvantages that go with it which includes even accepting material from donors with suboptimal health. But the invention here builds a fecal composition that goes through intense donor screening, multiple filtration steps that remove non-living material and freezes the composition to preserve its viability. Above all, the composition is almost odorless, in concentrated form and makes useful composition of colon microflora readily available for physicians to treat their patients. The composition invented here comprises of fecal microbes that are present in the gut, intestine and colon of healthy individuals obtained by processing fecal material (human stool). Before processing, the stool comprises of non-living material (this includes undigested fiber, dead bacteria, proteins, fats, carbohydrates, mucus, bile and other foods) and biological material. Biological material includes bacteria, archaea, fungi and viruses. The composition might be given to the patient in any of the suitable methods that would inject the good protozoans into the gastrointestinal tract. Methods used could be rectal administration (enema, upper endoscopy or colonoscopy), intubation through the nose or the mouth (nasoenteric tube or nasogastric tube) and oral administration (pill or capsule). While the concept of fecal transfer seems disgusting the procedure is lifesaving and has tremendous potential in becoming one of the most sought-after medical procedures in history. The patent was published on 13th September 2012 and for more details on the patent please visit:
United States Patent & Trademark Office: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=6&f=G&l=50&co1=AND&d=PTXT&s1=transplantation&s2=%22colon+microbiota%22&OS=transplantation+AND+%22colon+microbiota%22&RS=transplantation+AND+%22colon+microbiota%22
European Patent Office: https://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=20180430&CC=PL&NR=2683390T3&KC=T3
World Intellectual Property Organization: https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012122478&_cid=P21-JXZV0M-84871-1
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