New Innovative Procedures for Difficult Diseases

New Innovative Procedures for Difficult Diseases

digestive system_womaniStock_000048443642_FullThe procedure is quick, inexpensive and has a 90 percent cure rate for some patients.

Fecal Microbiota Transplantation, or FMT, is a hot topic in consumer medical literature. In fact, not since a former NBC News personality had a colonoscopy on live television 15 years ago has anything generated as much interest, believes I. David Shocket, MD, a MedStar Washington Hospital Center gastroenterologist with 26 years of experience.

“I put FMT right up there with some of the big events in the field of gastroenterology,” he says. “When Katie Couric got a colonoscopy, it was mind-boggling, the number of people who got colonoscopies. But this is huge too, and will take off, once it’s approved.”

Originally an ancient Chinese remedy known as “yellow soup,” FMT is a procedure that helps restore normal flora to the gastrointestinal tract, by transplanting stool from a donor by colonoscopy, endoscopy, sigmoidoscopy or enema. Currently considered an experimental treatment by the Food and Drug Administration for patients with Crohn’s or other Inflammatory Bowel Diseases (IBD), doctors may provide FMT to patients with Clostridium difficile infections, as long as the treating physician obtains informed patient consent. This position follows a January 2013 New England Journal of Medicine randomized study, which showed a 94 percent recovery rate for those who underwent FMT, compared to less than a third of patients who recovered when given vancomycin.

“When you see the results it’s astounding,” says Dr. Shocket. “For C.diff it is absolutely amazing. There is no drug that can compete against it.”

That was the case for a local college student who recently underwent FMT in January. After initially contracting C.diff after taking antibiotics for recurrent sinusitis and ear infections, the student was prescribed varying antibiotics to cure the infection, including FlagylTM, Bentyl and two tapering courses of vancomycin. While the patient would experience initial relief with antibiotic treatment, the C.diff returned four different times.

After more than a year of struggling with diarrhea, weight loss and overall malaise, the student was willing to try anything, including FMT from a screened donor. She said she noticed significant improvements within the first two days after FMT, which was administered by colonoscopy.

On a recent follow-up visit to Dr. Shocket, who did not perform the FMT but follows the patient in clinic, repeat stool testing was negative for C.diff.

Crohn’s and IBD

While the FDA has not approved FMT for uses outside of C.diff, clinical trials are underway for Crohn’s and other inflammatory bowel diseases. Ira Rabin, MD, vice president, Medical Operations, is part of one such trial. Eleven years ago, Dr. Rabin developed Crohn’s disease after taking an antibiotic for bronchitis. He had a fecal transplant in June 2014, and is awaiting the results of the trial.

According to Dr. Rabin, the FMT was no different than a routine colonoscopy. “Two hours after having it done, I was on an airplane, and I was back at work the next day,” he says.

While Dr. Rabin admits his Crohn’s is generally well-controlled by diet and probiotics, he has noted clinical improvement after the transplant. He also encourages others who suffer with IBD to talk to their doctor, about whether they would be a good candidate to pursue FMT.

“People should be open to it,” Dr. Rabin says. “There is no aspect about it I regret, and I would do it again if needed. And, if people are sick enough,” he adds, “all the preconceived notions that people may have about this will go out the window. I believe this will become a standard treatment for C.diff.”

An Infectious Disease

A spore-forming, Gram-positive anaerobic bacillus that produces two exotoxins, C.diff can cause nausea, abdominal pain, loss of appetite, fever and watery diarrhea. Generally, the elderly and those with compromised immune systems are most susceptible to the infectious disease. According to the Centers for Disease Control and Prevention, C.diff was responsible for almost half a million infections and was associated with approximately 29,000 deaths in 2011.

Glenn Wortmann, MD, director, Infectious Diseases reports most people who acquire C.diff respond well to initial antibiotic treatment. Approximately 15 to 20 percent will suffer a relapse, he notes, and most of those patients will recover with a second course of antibiotics. FMT, he explains, is limited to people who have failed repeated traditional therapies for C.diff.

“I do foresee seeing the Hospital Center doing this down the road,” he says. He is also hopeful that the bacteria from stool can be harnessed and eventually designed to be taken in other formats.

Gregory J. Argyros, MD, MACP, FCCP, sr. vice president, Medical Affairs and Chief Medical Officer also embraces FMT. “C.diff is becoming an increasingly common infection,” he says. “It can happen to anyone with exposure to antibiotics, and can be a serious and life-threatening disease.”

“This is a great example of thinking outside the box,” he continues. “What initially may seem like an idea that is way out there may truly have life-saving benefits. I think we will be seeing more and more of it in the future.”

For more information about FMT,
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What is FMT?

FMT, or Fecal Microbiota Transplantation, is a procedure in which fecal matter is collected from a tested donor, mixed with a saline or other solution, strained and placed in a patient, by colonoscopy, endoscopy, sigmoidoscopy or enema. The purpose of FMT is to replace good bacteria that has been killed or suppressed, usually by the use of antibiotics. The elimination of good bacteria causes bad bacteria, specifically Clostridium difficile, to over-populate the colon. This infection causes a condition called C.diff colitis, resulting in often debilitating, and sometimes fatal diarrhea.