Increasing incidence of Clostridium difficile infections…

Are Fecal Transplants the Answer?

Clostridium difficile infections the more serious toxic (CDI) have risen in number and megacolon that results in a severity at an alarming rate mortality rate of 38% to 80%. recently. It is now estimated that between 500,000 and Patients with recurring CDI 700,000 cases of CDI occur make good candidates for stool annually in US hospitals and transplant from a healthy donor, By Jay Hardy, CLS, SM (NRCM) long-term care facilities with an now known as Fecal

estimated hospital excess cost Microbiome Transplantation of care of approximately 3.2 (FMT), used to restore the

Jay Hardy is the founder and billion dollars. The CDC reports normal microbiota of the bowel president of Hardy Diagnostics. that there are about 14,000 and relieve suffering. He began his career in deaths due to CDI every year. microbiology as a Medical Technologist in Santa Barbara, The use of human fecal material California. CDI is usually associated with for therapeutic purposes is not

In 1980, he began manufacturing hospitalized patients that have new. The first recorded use culture media for the local been on antibiotic therapy, dates back to the fourth century hospitals. Today, Hardy usually clindamycin, in China in which a fecal Diagnostics is the third largest culture media manufacturer in the cephalosporins, or suspension was ingested by United States. fluoroquinolones. Severe mouth for severe food diarrhea follows due to the poisoning and diarrhea. There To ensure rapid and reliable turn around time, Hardy Diagnostics formation of toxins A and B are other references to the use

maintains eight distribution from resistant C. difficile, of stool products used by enema

centers, and produces over 3,500 causing severe mucosal in China in the 16th century. products used in clinical and industrial microbiology destruction and laboratories throughout the world. pseudomembrane formation.

One of the most frustrating

features of CDI is its ability to keep coming back with increasing intensity. Patients with CDI will experience multiple recurrences at rates

reported as high as 30%. Up to 3% of CDI patients will develop In the 17th century, FMT was MPH, stated: This study opens first used by veterinarians who the doors for an innovative, called the procedure inexpensive and natural “transfaunation.” alternative to improve outcomes of this debilitating disease with The first modern day use of billions of dollars in health care FMT in humans was reported in cost. 1958 for the treatment of pseudomembranous colitis. A recent randomized, controlled There was a resurgence of trial of FMT for patients with interest in FMT for the recurrent C. difficile diarrhea treatment of CDI in the 1980’s. was found to be successful in 94% of patients, the majority The success rate of FMT is requiring only one treatment. nothing less than astounding. In The trial was terminated early, a recent meta-analysis of eleven because it was felt to be studies, Kassam reported that unethical not to offer the 245 of 273 patients who treatment to all patients in the received FMT experienced trial due to the outstanding What follows is a brief clinical resolution of their success (van Nood et al. NEJM, description of the method disease with no reported January 31, 2013). recommended by the American adverse events (Kassan, et al, Gastroenterological Association Am J Gastroenterol. FMT can be carried out by (AGA) as explained by David 2013;108(4)). The authors nasogastric intubation, by Johnson, MD, Professor of concluded that the 90% success enema (sometimes self- Medicine and Chief of rate make FMT a technique that administered), or by Gastroenterology at Eastern definitely holds promise and colonoscopy. The nasogastric Virginia Medical School. that further randomized- method has obvious controlled trials are needed. disadvantages due to repulsive Patient Selection Other studies show an sight and smell issues impressive cure rate of up to experienced by the patient. In The first step in the FMT 98%. addition, it has proven not to be procedure is to identify the as effective as other methods. candidate for the procedure. FMT has also been reported as An enema is also not as The AGA recommends successful in treating effective since the higher selecting patients with three or Inflammatory Bowel Disease regions of the colon cannot be more recurring episodes or at (IBD), Irritable Bowel reached. Transplantation least two hospitalizations due to Syndrome (IBS), and ulcerative through colonoscopy appears to CDI. These patients have colitis. A recent study be the current method of choice, experienced treatment failures performed on children with since the donor bacteria can be with antibiotics, which is ulcerative colitis in Grand placed into the ileum of the usually metronidazole or Rapids, Michigan showed that small intestine and throughout vancomycin. 78% of children with this the entire large intestine. disease responded favorably Donor Selection within one week. The lead author, Sachin Kunde, MD, As for the selection of the transplantation material, the donor must be healthy and made clean for the colonoscopy episode. Additionally, 53% appropriately screened for procedure so that there is no stated that they would choose blood borne pathogens (such as residual stool. FMT as first-line therapy before AIDS and hepatitis), parasitic taking antibiotics. infections (such as giardia and cryptosporidium), and must be Transplantation Procedure To alleviate the psychological free from all intestinal diseases reversion to FMT, research is (such as irritable bowel disease, During the colonoscopy, from currently being conducted to diarrhea, and constipation). The 300 to 500ml of the fecal produce a probiotic soup of necessary screening tests can solution is then flushed starting about 20 enteric bacteria species cost about $500 which may or with the terminal ileum of the as a sort of “artificial feces.” may not be covered by small intestine and continued insurance. The donor must not down into the entire colon. The have taken any antibiotics for at patient is then given Imodium® FMT for Non-GI Disease least three months. If the (loperamide) in order to slow recipient has any food allergies, down stool transit. Encouraged by the amazing then the donor must refrain success of FMT in treating GI from eating the offending foods illness, there is new research for at least five days previous to being done on treating non-GI the procedure. All antibiotic diseases as well. Encouraging therapy is discontinued for at results have been reported in least three days prior to the treating chronic fatigue transplantation. syndrome, obesity, autism, and autoimmune diseases with Fecal Preparation FMT.

Difficulties with Infection Results Control

Molecular techniques show that Efforts to control CDI with bacteria in the recipient’s stool improved hygiene in the closely resemble those of the hospital setting have been donor about two weeks after disappointing. According to a

FMT and are usually dominated recent APIC survey, 70% of To prepare the specimen, a by Bacteroides spp. infection control specialists say 50gm stool sample is mixed they have implemented with bacteriostatic saline, Patient Acceptance additional intervention methods, blended under a hood, and but only 42% have seen a filtered through gauze to Surprisingly, FMT was found to decline in the number of remove particulate matter. be readily accepted by patients. infections. Bleach is used by

In the recent multicenter study, 67% of hospitals for room This solution must be 97% of patients with recurring cleaning, and 9% use newer UV transplanted within 6 to 8 hours. CDI reported a willingness to light and vaporized hydrogen Frozen samples have also been undergo another FMT if they peroxide methods. 72% say successfully used. The patient’s were to have a repeat CDI they have stepped up their bowel is then prepped to be promotion of hand washing and Conclusion the use of alcohol sanitizers. However, C. difficile spores are Due to the failure to control resistant to alcohol exposure. CDI by standard sanitization procedures, it is hoped that more patients can be spared the agony of this devastating disease by implementing the use of fecal transplantation, in spite of the apparent initial hesitancy on the part of patient and physician.

The FMT procedure is slowly gaining in acceptance among clinicians. A new Current Clostridium difficile, a gram positive Procedural Terminology (CPT) rod that grows anaerobically and produces spores, seen here as light code (44705, "Preparation of sections within the cell. fecal microbiota for instillation, including assessment of donor specimen") has been assigned to Much of these efforts may seem FMT. futile for some patients, since a recent study found that 10% of Within the hospital, the all patients were found to be question often asked is, who asymptomatic carriers of C. will prepare the FMT difficile upon admission specimen? The clinical (Leekha, American Journal of laboratory? The GI lab? The Infection Control, May 2013). pharmacy? Many issues still need to be resolved before this procedure becomes routine.

As long as antibiotic therapy is used, and sometimes overused, there will be an increasing need for alternative life saving techniques to restore a healthy intestinal microbiome, no matter how revolting it may initially seem.

Jay Hardy

Source: Google images Santa Maria, California

The information contained in this article is for educational purposes only and is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment.