Stool Transplants

Fecal microbiota transplants boast a greater than 90% success rate for patients with C. diff

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Fecal microbiota transplants may just revolutionize healthcare. The procedure is most commonly performed to treat clostridium difficile (C. diff), an infection that kills nearly 14,000 Americans each year. Promising research indicates potential applications in the treatment of diseases and disorders such as colitis (including ulcerative colitis and Crohn's disease), Multiple Sclerosis, Parkinson's disease, rheumatoid arthritis, diabetes, autism, irritable bowel syndrome, acne and obesity.

Offered in just a handful of facilities nationwide, fecal microbiota transplants (FMTs) or stool transplants are quickly gaining the attention of patients with C. diff, and will likely become more widely available at a rapid rate. The U.S. Food and Drug Administration cleared the way for a growing number of FMTs with its 2013 announcement that physicians no longer need to receive agency approval before performing the procedure.

The procedure involves the infusion of a normal, healthy donor stool that replenishes the normal bacterial flora of a patient's colon, according to Razvan I. Arsenescu, MD, PhD, associate professor and director, Inflammatory Bowel Diseases Center at The Ohio State University Wexner Medical Center in Columbus, Ohio.

FMT has been highly effective in individuals with refractory and recurrent C. diff infection who have not responded to all conventional therapies. Prior to the transplant, the fresh stool from a healthy donor is screened for various diseases and known pathogens that could be transmitted to the patient.

"A gastroenterologist performs a colonoscopy, and infuses the liquefied donor stool using a syringe into the final portion of the small intestine and right side of the colon to repopulate healthy bacteria," Arsenescu said.

Altered intestinal microflora, or microbiome, has wide reaching impacts, explained Sanjay Jagannath, MD, director, the Center for Comprehensive Pancreatic Care at Mercy Medical Center in Baltimore, Md. "We only need to fight the organisms that are bad; we can live in harmony with the good organisms or the ones that are not causing us harm," he stated.

According to Jagannath, the health of an individual's microbes plays a big role in immunity, energy and metabolism. Microbes are necessary for the human's ability to eat, breathe and function. "There are more than a trillion microorganisms living in our bodies and they are responsible for a lot of good things," he said. "When that balance is upset, our systems don't work correctly."

Overwhelming Outcomes
Mercy Medical Center has completed about 40 FMTs in the past two years in patients with refractory C. diff only. According to Jagannath, FMT is a cost-effective and result-effective way to treat this patient population.

Antibiotics have interfered with the systems of these individuals and physicians need to find the balance. "Our personal success rate is a 92 percent outcome," Jagannath said. "The patients who have failed the first treatment and needed a second treatment all had an antibiotic prescribed indiscriminately. These are patients who went to the ED for a cough after the FMT, were prescribed medicine when not needed, and ended up with recurring C. diff."

Prior to the procedure, Jagannath evaluates the patient and speaks with the family and potential donor. "I follow up the initial evaluation with a questionnaire to screen the donor and finally, a formal screen process," he said.

According to experts at Ohio State's Wexner Medical Center, the minimum criteria for candidates is a refractory C. diff infection despite at least two courses of standard therapy or at least two episodes of documented, symptomatic C. diff infection, despite adequate treatment with appropriate antibiotic therapies.

"A stool transplant is believed to populate the bowel with healthy bacteria that can fend off C. diff by multiple mechanisms, secrete molecules that kill or impair growth of C. diff, consume nutrients that C. diff needs or trigger a body response that will get rid of C. diff," explained Arsenescu. Ohio State's Wexner Medical Center currently performs this procedure for C. diff as well as selected inflammatory bowel disease cases, including Crohn's disease and ulcerative colitis.

Jagannath stresses that the procedure is safe. "Many patients express a fear of transmitting infection with this procedure but the outcomes are off the charts, even for patients with compromised immune systems from end-stage liver disease to HIV/AIDS."

"The intestine of a normal patient is complicated with thousands of species of bacteria living in the colon," said Herbert L. DuPont, MD, MACP, chief of internal medicine services at Baylor St. Luke's Medical Center, part of CHI St. Luke's Health, in Houston, Texas.

DuPont has performed more than 30 procedures for C. diff and has reserved double that number of stools for patients in the future. "The good bacterium disappears when a patient is treated with antibiotics. When a patient loses diversity of bacteria, then he cannot resist infection," he said. "These bugs are like gates to prevent issues. By replenishing with healthy diverse bacteria, then the problem is solved."

Are Stool Banks the Next Step?
"This procedure is miraculous because it reverses months and years of suffering almost instantaneously," observed DuPont. "We are attracting patients from all over Texas, California and other nearby states. The word is out. It's no secret anymore."

As a result of excitement surrounding the procedure, stool banks are slowly surfacing in the private and public sectors. "The criteria established for selecting donors is still evolving," explained Arsenescu. "The development of so-called stool banks will likely streamline the process."

When donors are screened at Baylor St. Luke's Medical Center, they are asked to give multiple donations. "We add saline to the samples, put the samples in freezer bags, bang the contents to emulsify the samples, and remove the stool-like content," stated DuPont, who is also director of the Center for Infectious Diseases at The University of Texas School of Public Health, and vice chairman of the department of medicine at Baylor College of Medicine in Houston.

DuPont chooses to use donors not related to the patient. "Some people use relatives and spouses of patients but bacteria from all [healthy] stools work," he told ADVANCE.

DuPont and his team have grand plans for the stools they are collecting. "We collect three samples from each donor and filter them twice. One sample is given fresh to a patient with C. diff, one is frozen and given to a patient at a later date and the last one is freeze dried to give to another patient," he explained. "When frozen bacteria samples work, then we can give them to patients across the country," stated DuPont. "And if freeze drying works, then we can eventually give the sample to patients in a capsule form."

Baylor St. Luke's Medical Center began a randomized study in April of patients receiving a frozen sample through an enema or an orally administered version of the freeze-dried sample. "Fresh samples are time consuming and inconvenient to the patient and the practitioner," DuPont noted. "When we make the switch to frozen samples, we will be able to treat five to10 patients a day. And the eventual move to capsules will open up all kinds of therapy avenues."

The possibilities for future applications of FMT are limitless. Jagannath believes continuing to study microbes in a scientific manner will be just as important, if not more so, than mapping the human genome.

Rebecca Mayer Knutsen is on staff at ADVANCE. Contact: rknutsen@advanceweb.com

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